Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT04182334
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Decreasing Delirium Through Music in Critically Ill Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bakhan@iu.edu', 'phone': '(317) 274-9132', 'title': 'Babar Khan, MD, MS', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.', 'eventGroups': [{'id': 'EG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 2, 'seriousNumAtRisk': 79, 'deathsNumAffected': 10, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 2, 'seriousNumAtRisk': 80, 'deathsNumAffected': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear/ earlobe skin breakdown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Days Free of Delirium and Coma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.775', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Seven day study intervention phase', 'description': 'Days free of delirium and coma will be the primary outcome for the trial. Days free of delirium and coma are the number of days after randomization patient is alive free of delirium and not in coma during the seven-day study intervention phase.', 'unitOfMeasure': 'Delirium/coma-free days by day 7', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Delirium Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.43', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '5.79', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.77', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.10', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.54', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '2.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.78', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.73', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.72', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '2.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.995', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Subjects will be followed up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.', 'description': 'Delirium severity was assessed twice daily by trained research assistants by the CAM-ICU-7, a seven point rating scale (0-7) where higher scores reflect higher delirium severity (worse outcomes). The CAM-ICU-7 score are categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. For the twice daily assessments, the mean of the two assessments was used.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'maximum number of participants analyzed during day 1 through day 7'}, {'type': 'SECONDARY', 'title': 'Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.674', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.', 'description': 'Pain will be assessed by trained research assistants utilizing the Critical Care Pain Observation Tool (CPOT), a valid and reliable instrument in critically ill patients with and without delirium.. Scale range 0-8, higher score indicates worse pain. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'maximum number of participants analyzed during day 1 through day 7'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.56', 'spread': '34.41', 'groupId': 'OG000'}, {'value': '43.13', 'spread': '33.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.40', 'spread': '33.49', 'groupId': 'OG000'}, {'value': '38.82', 'spread': '34.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.38', 'spread': '37.45', 'groupId': 'OG000'}, {'value': '35.39', 'spread': '38.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.86', 'spread': '36.36', 'groupId': 'OG000'}, {'value': '39.50', 'spread': '33.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.72', 'spread': '30.23', 'groupId': 'OG000'}, {'value': '53.50', 'spread': '38.97', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.36', 'spread': '35.40', 'groupId': 'OG000'}, {'value': '37.80', 'spread': '44.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.63', 'spread': '24.67', 'groupId': 'OG000'}, {'value': '28.83', 'spread': '38.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.326', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.', 'description': 'Anxiety intensity defined as a heightened state of apprehension, agitation, and arousal, will be measured four times daily before and after assigned intervention using a 100-mm Visual Analog Scale-Anxiety (VAS-A). Scale range 0-100, higher score indicates worse anxiety. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'maximum number of participants analyzed during day 1 through day 7'}, {'type': 'SECONDARY', 'title': 'Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'title': 'AVTL Total Learning', 'categories': [{'measurements': [{'value': '32.23', 'spread': '13.14', 'groupId': 'OG000'}, {'value': '35.76', 'spread': '12.10', 'groupId': 'OG001'}]}]}, {'title': 'AVTL Delayed Recall', 'categories': [{'measurements': [{'value': '5.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.463', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post hospital discharge', 'description': 'Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Auditory Verbal Learning Test \\[AVLT\\] will be administered using a phone-based format. During test administration there are 5 learning trials. After a 30-minute delay, the participants are asked to recall as many words as possible. The sum of learning trials are presented as scores ranging from 0-75, and for the 30-minute delay test scores range from 0-15. A lower score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.85', 'spread': '6.08', 'groupId': 'OG000'}, {'value': '13.88', 'spread': '4.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.449', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post hospital discharge', 'description': 'Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Wechsler Adult Intelligence Scale- III Digit Span test will be administered using a phone-based format. Score range 0-30, a lower score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.10', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '30.13', 'spread': '12.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.505', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post hospital discharge', 'description': 'Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Symbol Digit Modalities Test will be administered using a phone-based format. Score range 0-110, a lower score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.31', 'spread': '14.46', 'groupId': 'OG000'}, {'value': '34.13', 'spread': '10.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.612', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post hospital discharge', 'description': 'Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Multilingual Aphasia Examination Controlled Oral Word Association test will be administered using a phone-based format. Score range 0-no max score, a lower score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.38', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '6.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post hospital discharge', 'description': "We will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of the music intervention on ICU survivor's mood. Scale range 0-27, higher score indicates worse depression.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.46', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '5.94', 'spread': '6.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post hospital discharge', 'description': "We will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of the music intervention on ICU survivor's anxiety. Scale range 0-21, higher score indicates worse anxiety.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'FG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}], 'preAssignmentDetails': 'Per protocol subjects were considered to be enrolled in the study at the time of completion of the informed consent process. 160 subjects were enrolled. 159 subjects were randomized to one of the two study groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.\n\nSlow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.'}, {'id': 'BG001', 'title': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.\n\nAttention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '67.9', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '160 subjects were enrolled, 159 subjects were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-22', 'size': 1005353, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-10T11:10', 'hasProtocol': True}, {'date': '2023-05-22', 'size': 222612, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-10T11:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the unblinded study coordinator is aware of randomization. Outcomes assessors are blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Slow Tempo Music vs Attention Control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2019-11-25', 'resultsFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2019-11-27', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-12-11', 'studyFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days Free of Delirium and Coma', 'timeFrame': 'Seven day study intervention phase', 'description': 'Days free of delirium and coma will be the primary outcome for the trial. Days free of delirium and coma are the number of days after randomization patient is alive free of delirium and not in coma during the seven-day study intervention phase.'}], 'secondaryOutcomes': [{'measure': 'Delirium Severity', 'timeFrame': 'Subjects will be followed up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.', 'description': 'Delirium severity was assessed twice daily by trained research assistants by the CAM-ICU-7, a seven point rating scale (0-7) where higher scores reflect higher delirium severity (worse outcomes). The CAM-ICU-7 score are categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. For the twice daily assessments, the mean of the two assessments was used.'}, {'measure': 'Pain Intensity', 'timeFrame': '4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.', 'description': 'Pain will be assessed by trained research assistants utilizing the Critical Care Pain Observation Tool (CPOT), a valid and reliable instrument in critically ill patients with and without delirium.. Scale range 0-8, higher score indicates worse pain. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used.'}, {'measure': 'Anxiety', 'timeFrame': '4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.', 'description': 'Anxiety intensity defined as a heightened state of apprehension, agitation, and arousal, will be measured four times daily before and after assigned intervention using a 100-mm Visual Analog Scale-Anxiety (VAS-A). Scale range 0-100, higher score indicates worse anxiety. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used.'}, {'measure': 'Cognition', 'timeFrame': '3 months post hospital discharge', 'description': 'Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Auditory Verbal Learning Test \\[AVLT\\] will be administered using a phone-based format. During test administration there are 5 learning trials. After a 30-minute delay, the participants are asked to recall as many words as possible. The sum of learning trials are presented as scores ranging from 0-75, and for the 30-minute delay test scores range from 0-15. A lower score indicates a worse outcome.'}, {'measure': 'Cognition', 'timeFrame': '3 months post hospital discharge', 'description': 'Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Wechsler Adult Intelligence Scale- III Digit Span test will be administered using a phone-based format. Score range 0-30, a lower score indicates a worse outcome.'}, {'measure': 'Cognition', 'timeFrame': '3 months post hospital discharge', 'description': 'Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Symbol Digit Modalities Test will be administered using a phone-based format. Score range 0-110, a lower score indicates a worse outcome.'}, {'measure': 'Cognition', 'timeFrame': '3 months post hospital discharge', 'description': 'Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Multilingual Aphasia Examination Controlled Oral Word Association test will be administered using a phone-based format. Score range 0-no max score, a lower score indicates a worse outcome.'}, {'measure': 'Depression', 'timeFrame': '3 months post hospital discharge', 'description': "We will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of the music intervention on ICU survivor's mood. Scale range 0-27, higher score indicates worse depression."}, {'measure': 'Anxiety', 'timeFrame': '3 months post hospital discharge', 'description': "We will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of the music intervention on ICU survivor's anxiety. Scale range 0-21, higher score indicates worse anxiety."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delirium', 'Music', 'Pain', 'Anxiety', 'Cognition'], 'conditions': ['Intensive Care Unit Delirium', 'Pain', 'Anxiety', 'Intensive Care Acquired Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '41082215', 'type': 'DERIVED', 'citation': 'Khan BA, Khan SH, Perkins AJ, Heiderscheit A, Unverzagt FW, Wang S, Downs JH 3rd, Gao S, Chlan LL. Slow-Tempo Music and Delirium/Coma-Free Days Among Older Adults Undergoing Mechanical Ventilation: A Randomized Clinical Trial. JAMA Intern Med. 2025 Dec 1;185(12):1442-1453. doi: 10.1001/jamainternmed.2025.5263.'}, {'pmid': '35854358', 'type': 'DERIVED', 'citation': 'Seyffert S, Moiz S, Coghlan M, Balozian P, Nasser J, Rached EA, Jamil Y, Naqvi K, Rawlings L, Perkins AJ, Gao S, Hunter JD 3rd, Khan S, Heiderscheit A, Chlan LL, Khan B. Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial. Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w.'}]}, 'descriptionModule': {'briefSummary': 'Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium. The investigators propose a randomized controlled trial to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.', 'detailedDescription': 'One million adults in the United States receive mechanical ventilation for acute respiratory failure in the intensive care units (ICUs) annually and up to 80% of them develop delirium during their ICU stay. Presence of delirium predisposes older adults to immediate in-hospital complications including a longer length of ICU and hospital stay, increased risk of in-patient mortality and elevated costs of care. In addition, ICU delirium is associated with long-term post-discharge complications such as development of cognitive impairment and dementia.\n\nRecent research studies exploring pharmacological strategies to manage ICU delirium have not demonstrated efficacy; a limitation also acknowledged in the Society of Critical Care Medicine 2018 Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption guidelines. Music listening is a non-pharmacological intervention that has shown to decrease over-sedation, anxiety and stress in critically ill patients, factors that could predispose to ICU delirium. Our team is now proposing to conduct a large randomized clinical trial called "Decreasing Delirium through Music (DDM) in Critically Ill Older Adults to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically-ventilated older adults admitted to the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 50 years or older.\n2. English speaking.\n3. Admitted to the intensive care unit (medical or surgical).\n4. Expected mechanical ventilator support for ≥48 hours.\n5. Consentable through a legally authorized representative.\n6. Have access to a telephone.\n\nExclusion Criteria:\n\n1. History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.\n2. Psychiatric illness which is not well controlled.\n3. Alcohol withdrawal symptoms/concern for withdrawal.\n4. Suspected or confirmed drug intoxication/overdose\n5. Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.\n6. Uncorrected hearing or vision impairment including legal blindness.\n7. Incarcerated at the time of study enrollment.\n8. Enrolled in another clinical trial which does not permit co-enrollment.\n9. Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures."}, 'identificationModule': {'nctId': 'NCT04182334', 'acronym': 'DDM', 'briefTitle': 'Decreasing Delirium Through Music in Critically Ill Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Decreasing Delirium Through Music in Critically Ill Older Adults', 'orgStudyIdInfo': {'id': '1906664366'}, 'secondaryIdInfos': [{'id': '5R01AG067631-03', 'link': 'https://reporter.nih.gov/quickSearch/5R01AG067631-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow Tempo Music', 'description': 'Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.', 'interventionNames': ['Other: Slow Tempo Music']}, {'type': 'SHAM_COMPARATOR', 'label': 'Attention Control', 'description': 'One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.', 'interventionNames': ['Other: Attention Control']}], 'interventions': [{'name': 'Slow Tempo Music', 'type': 'OTHER', 'description': 'For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.', 'armGroupLabels': ['Slow Tempo Music']}, {'name': 'Attention Control', 'type': 'OTHER', 'description': 'Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.', 'armGroupLabels': ['Attention Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health West Hospital', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eskenazi Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Babar Khan, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Linda Chlan, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Babar Khan, MD, MS', 'investigatorAffiliation': 'Indiana University'}}}}