Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-03 @ 2:41 PM
Study NCT ID:
NCT02413294
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2015-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sleep to Activate Mood Promotion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leggetta@med.umich.edu', 'phone': '734-232-0538', 'title': 'Dr. Amanda Leggett', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 29 days', 'eventGroups': [{'id': 'EG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study.", 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pittsburgh Sleep Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000'], 'pValueComment': 'This t-test analyzes the change in mean between the midpoint interview immediately prior to the start of the intervention and the follow-up interview at the conclusion of the intervention.', 'groupDescription': 'The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'two weeks after introduction of intervention', 'description': 'The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Health Questionnaire-9 Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000'], 'groupDescription': 'The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'two weeks after introduction of intervention', 'description': 'The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Insomnia Severity Index Sum Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'categories': [{'measurements': [{'value': '11.36', 'spread': '5.89', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000'], 'groupDescription': 'The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'two weeks after introduction of intervention', 'description': 'The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28. A score of 15 or higher is indicative of clinical insomnia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Morningness-Eveningness Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'categories': [{'title': 'morning types', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'intermediate type', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'evening types', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000'], 'groupDescription': 'The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'two weeks after introduction of intervention', 'description': 'The morningness- eveningness categories represent the time of day when a person is at their peak alertness.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Actigraph Sleep Data: Minutes Asleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '405.2', 'spread': '27.9', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '402.2', 'spread': '24.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'mean nightly sleep duration for each of the two-week periods: baseline and intervention', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Actigraph: Number of Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '22.1', 'spread': '6.2', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '22.4', 'spread': '5.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'Actigraphy counts awakenings by using an accelerometer to assess motion during the night. The number of awakenings is the mean nightly number of awakenings during each of the two-week periods: baseline and intervention.', 'unitOfMeasure': 'count of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Actigraph: Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '85.0', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '85.1', 'spread': '4.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100). The mean for each of the two-week periods: baseline and intervention, is calculated.', 'unitOfMeasure': 'percentage of time in bed spent asleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fitbit Sleep Data: Sleep Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '425.4', 'spread': '33.6', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '428.3', 'spread': '36.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention', 'unitOfMeasure': 'Minutes asleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fitbit Sleep Data: Night Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '13.4', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '15.8', 'spread': '11.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'mean nightly awakenings for each of the two week periods: baseline and intervention. Similar to the actigraph the Fitbit counts awakenings through an accelerometer which measures motion.', 'unitOfMeasure': 'count of night awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fitbit Sleep Data: Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '91.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '90.6', 'spread': '4.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).', 'unitOfMeasure': 'percentage of time in bed spent asleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-Reported Sleep Diary: Time at Which Participants go to Bed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '24', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '23.8', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': 'Bed time represents the moment in time at which participants went to bed, measured on a revised clock where 6pm = 18, Midnight = 24 and 6am =30. Time between actual hours is calculated on a decimal basis, so an additional 6 minutes = .1. This revised clock is necessary in order to make means work properly in the nighttime hours. Otherwise, averaging between a 10pm bedtime and a 2am bedtime would give the impossible, inaccurate mean of being in the daytime between those two numbers.', 'unitOfMeasure': 'hour (military time)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-Reported Sleep Diary: Time at Which Participants Wake up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer us', 'categories': [{'measurements': [{'value': '7.8', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': '2 weeks of ReTimer use', 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': 'Wake time represents the moment in time at which participants awaken. Time between actual hours is calculated on a decimal basis so an additional 6 minutes = .1. so that 7.5 represents 7:30 a.m. and 7.8 represents 7:48 a.m.', 'unitOfMeasure': 'hour (military time)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-Reported Sleep Diary: Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': "sleep quality is a participants' mean self-report for each of the two week periods: baseline and intervention. Sleep quality is reported for each night on a scale of 0 (very poor) to 4 (very good).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-Reported Sleep Diary: Night Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': 'mean number of night awakenings per person per night as reported in sleep diaries', 'unitOfMeasure': 'Number of night awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-Reported Sleep Diary: Sleep Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'classes': [{'title': '2 weeks monitoring prior to ReTimer use', 'categories': [{'measurements': [{'value': '429.3', 'spread': '28.2', 'groupId': 'OG000'}]}]}, {'title': '2 weeks with ReTimer Glasses', 'categories': [{'measurements': [{'value': '433.3', 'spread': '56.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000'], 'groupDescription': 'Pre-intervention period means are compared to intervention period means for all subjects.', 'statisticalMethod': 'Paired T test, 2-sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': 'nightly mean of length of sleep measured in minutes', 'unitOfMeasure': 'Minutes asleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.\n\nRe-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Asian American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patient Health Questionnaire-9', 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '3.9', 'groupId': 'BG000'}]}]}, {'title': 'After 2 wks sleep tracking/prior to intervention', 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pittsburgh Sleep Quality Index', 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.3', 'spread': '4.1', 'groupId': 'BG000'}]}]}, {'title': 'After 2 wks sleep tracking/prior to intervention', 'categories': [{'measurements': [{'value': '7.6', 'spread': '3.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insomnia Severity Index', 'classes': [{'title': 'Initial baseline measurement', 'categories': [{'measurements': [{'value': '13.09', 'spread': '4.85', 'groupId': 'BG000'}]}]}, {'title': 'After 2 wks sleep tracking/prior to intervention 3', 'categories': [{'measurements': [{'value': '11.86', 'spread': '5.51', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28. A score of 15 or higher is indicative of clinical insomnia.\n\nData for all 11 participants is provided at two baseline time points:\n\nprior to wearing a monitor at all, and after two weeks of wearing a monitoring device, prior to use of ReTimer glasses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Morningness/Eveningness Questionnaire', 'classes': [{'categories': [{'title': 'Morning type', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Intermediate type', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Evening type', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline measures are given for the study sample that completed study procedures.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2015-04-06', 'resultsFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-04', 'studyFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'two weeks after introduction of intervention', 'description': 'The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.'}, {'measure': 'Patient Health Questionnaire-9 Depression Scale', 'timeFrame': 'two weeks after introduction of intervention', 'description': 'The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.'}, {'measure': 'Insomnia Severity Index Sum Scores', 'timeFrame': 'two weeks after introduction of intervention', 'description': 'The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28. A score of 15 or higher is indicative of clinical insomnia.'}, {'measure': 'Morningness-Eveningness Questionnaire', 'timeFrame': 'two weeks after introduction of intervention', 'description': 'The morningness- eveningness categories represent the time of day when a person is at their peak alertness.'}], 'secondaryOutcomes': [{'measure': 'Actigraph Sleep Data: Minutes Asleep', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'mean nightly sleep duration for each of the two-week periods: baseline and intervention'}, {'measure': 'Actigraph: Number of Awakenings', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'Actigraphy counts awakenings by using an accelerometer to assess motion during the night. The number of awakenings is the mean nightly number of awakenings during each of the two-week periods: baseline and intervention.'}, {'measure': 'Actigraph: Efficiency', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100). The mean for each of the two-week periods: baseline and intervention, is calculated.'}, {'measure': 'Fitbit Sleep Data: Sleep Duration', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention'}, {'measure': 'Fitbit Sleep Data: Night Awakenings', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'mean nightly awakenings for each of the two week periods: baseline and intervention. Similar to the actigraph the Fitbit counts awakenings through an accelerometer which measures motion.'}, {'measure': 'Fitbit Sleep Data: Sleep Efficiency', 'timeFrame': 'daily for 4 weeks- baseline and intervention period', 'description': 'Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).'}, {'measure': 'Self-Reported Sleep Diary: Time at Which Participants go to Bed', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': 'Bed time represents the moment in time at which participants went to bed, measured on a revised clock where 6pm = 18, Midnight = 24 and 6am =30. Time between actual hours is calculated on a decimal basis, so an additional 6 minutes = .1. This revised clock is necessary in order to make means work properly in the nighttime hours. Otherwise, averaging between a 10pm bedtime and a 2am bedtime would give the impossible, inaccurate mean of being in the daytime between those two numbers.'}, {'measure': 'Self-Reported Sleep Diary: Time at Which Participants Wake up', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': 'Wake time represents the moment in time at which participants awaken. Time between actual hours is calculated on a decimal basis so an additional 6 minutes = .1. so that 7.5 represents 7:30 a.m. and 7.8 represents 7:48 a.m.'}, {'measure': 'Self-Reported Sleep Diary: Sleep Quality', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': "sleep quality is a participants' mean self-report for each of the two week periods: baseline and intervention. Sleep quality is reported for each night on a scale of 0 (very poor) to 4 (very good)."}, {'measure': 'Self-Reported Sleep Diary: Night Awakenings', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': 'mean number of night awakenings per person per night as reported in sleep diaries'}, {'measure': 'Self-Reported Sleep Diary: Sleep Duration', 'timeFrame': 'daily for 4 weeks- baseline and intervention period to be compared', 'description': 'nightly mean of length of sleep measured in minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Sleep Quality']}, 'descriptionModule': {'briefSummary': 'The investigators are aiming to examine the acceptability and feasibility of a portable bright light therapy instrument to improve sleep disturbance in a preventive intervention for depression. The investigators will conduct an intervention that trials the use of bright light glasses called "re-timers" as a preventive intervention in older adults with sleep disturbance and subsyndromal symptoms of depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years of age or older\n* 6 or greater on the Pittsburgh Sleep Quality Index\n* A score of 5 to 9 on the Patient Health Questionnaire-9 Depression Scale\n\nExclusion Criteria:\n\n* Active suicidal ideation\n* Presence of mania or bipolar disorder\n* Presence of an eye disease\n* Prescription of a photosensitizing medication\n* Having previously had eye surgery'}, 'identificationModule': {'nctId': 'NCT02413294', 'acronym': 'STAMP', 'briefTitle': 'Sleep to Activate Mood Promotion', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Sleep to Activate Mood Promotion- Intervention', 'orgStudyIdInfo': {'id': 'HUM00094645'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright Light Intervention', 'description': "Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.", 'interventionNames': ['Device: Re-Timer glasses']}], 'interventions': [{'name': 'Re-Timer glasses', 'type': 'DEVICE', 'description': 'Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study.', 'armGroupLabels': ['Bright Light Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Amanda N Leggett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Research Fellow', 'investigatorFullName': 'Amanda Leggett', 'investigatorAffiliation': 'University of Michigan'}}}}