Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-04-22 @ 12:16 PM
Study NCT ID:
NCT03055156
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2015-08-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nishino@stanford.edu', 'phone': '650-725-8602', 'title': 'Dr. Seiji Nishino', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Study visit overnight (up to 24hrs)', 'eventGroups': [{'id': 'EG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.', 'otherNumAtRisk': 281, 'deathsNumAtRisk': 281, 'otherNumAffected': 0, 'seriousNumAtRisk': 281, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 273, 'otherNumAffected': 0, 'seriousNumAtRisk': 273, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.62', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '6.55', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Sleep Efficiency Assessed by Polysomnography (PSG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.87', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '79.73', 'spread': '14.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': "Sleep efficiency is total sleep time divided by time in bed. All data were collected through the PSG data that were retrieved from the patients' medical records after completion of the recordings and analysis by the sleep technologists.", 'unitOfMeasure': 'percentage time in bed asleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Sleep Latency Assessed by PSG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.67', 'spread': '21.00', 'groupId': 'OG000'}, {'value': '24.05', 'spread': '25.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'The amount of time from lights off to falling asleep.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Wake After Sleep Onset (WASO) Assessed by PSG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.09', 'spread': '43.57', 'groupId': 'OG000'}, {'value': '74.36', 'spread': '67.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'Total amount of minutes awake after the first sleep epoch.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Time in Bed During Each Sleep Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'title': 'Wake', 'categories': [{'measurements': [{'value': '17.11', 'spread': '11.38', 'groupId': 'OG000'}, {'value': '20.16', 'spread': '14.92', 'groupId': 'OG001'}]}]}, {'title': 'REM', 'categories': [{'measurements': [{'value': '16.26', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '14.92', 'spread': '7.52', 'groupId': 'OG001'}]}]}, {'title': 'Non REM stage 1', 'categories': [{'measurements': [{'value': '6.36', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': 'Non REM stage 2', 'categories': [{'measurements': [{'value': '47.67', 'spread': '12.22', 'groupId': 'OG000'}, {'value': '47.36', 'spread': '12.69', 'groupId': 'OG001'}]}]}, {'title': 'Non REM stage 3', 'categories': [{'measurements': [{'value': '11.86', 'spread': '10.58', 'groupId': 'OG000'}, {'value': '11.81', 'spread': '16.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of Wake values', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of REM values', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of Non REM stage 1 values', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of Non REM stage 2 values', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of Non REM stage 3 values', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'unitOfMeasure': 'percentage of time in bed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Position Changes Assessed by PSG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.64', 'spread': '12.76', 'groupId': 'OG000'}, {'value': '15.65', 'spread': '10.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'Number of times participant changed position during the sleep recording.', 'unitOfMeasure': 'number of position changes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Apnea Hypopnea Index Assessed by PSG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.15', 'spread': '57.00', 'groupId': 'OG000'}, {'value': '33.86', 'spread': '45.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'The number of apneas or hypopneas recorded during the study per hour of sleep.', 'unitOfMeasure': 'number of events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.24', 'spread': '14.19', 'groupId': 'OG000'}, {'value': '64.82', 'spread': '10.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Periodic Leg Movements (PLM) During Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.56', 'spread': '143.43', 'groupId': 'OG000'}, {'value': '91.51', 'spread': '11.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'Number of times participant had periodic leg movements during the sleep recording', 'unitOfMeasure': 'number of PLM events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'title': '0-90min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.34', 'spread': '30.71', 'groupId': 'OG000'}, {'value': '31.93', 'spread': '36.61', 'groupId': 'OG001'}]}]}, {'title': '90-180min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.61', 'spread': '31.56', 'groupId': 'OG000'}, {'value': '32.00', 'spread': '32.61', 'groupId': 'OG001'}]}]}, {'title': '180-270min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.19', 'spread': '31.55', 'groupId': 'OG000'}, {'value': '27.02', 'spread': '67.62', 'groupId': 'OG001'}]}]}, {'title': '270-360min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.66', 'spread': '38.68', 'groupId': 'OG000'}, {'value': '20.07', 'spread': '23.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'analysis of 0-90 minutes', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'analysis of 90-180 minutes', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'analysis of 180-270 minutes', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'analysis of 270-360 min', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'EEG data collected from the electrode in position C2', 'unitOfMeasure': 'µV^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Core Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'title': '30min since lights off', 'categories': [{'measurements': [{'value': '36.42', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '36.29', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': '60min since lights off', 'categories': [{'measurements': [{'value': '36.49', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '36.52', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': '90min since lights off', 'categories': [{'measurements': [{'value': '36.46', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '36.49', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': '120min since lights off', 'categories': [{'measurements': [{'value': '36.47', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '36.51', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': '150min since lights off', 'categories': [{'measurements': [{'value': '36.51', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '36.53', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': '180min since lights off', 'categories': [{'measurements': [{'value': '36.54', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '36.56', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': '210min since lights off', 'categories': [{'measurements': [{'value': '36.56', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '36.57', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': '240min since lights off', 'categories': [{'measurements': [{'value': '36.59', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '36.61', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': '270min since lights off', 'categories': [{'measurements': [{'value': '36.58', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '36.64', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': '300min since lights off', 'categories': [{'measurements': [{'value': '36.59', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '36.65', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': '330min since lights off', 'categories': [{'measurements': [{'value': '36.61', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '36.64', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': '360min since lights off', 'categories': [{'measurements': [{'value': '36.62', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '36.63', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.389', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to compare the difference in core body temperature trend over time between the two study arms. Interaction between time and topper type on CBT was calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect over time from both study arms on CBT. Main effect of time on CBT.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.642', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect of the intervention on CBT including all time points. Main effect of topper type on CBT.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'Difference in core body temperature changes of the high and low rebound mattress toppers at sleep onset and during sleep. The core body temperature will be monitored every minute throughout the night.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.93', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'visual analog scale of sleep was used for evaluation of subjective sleep quality. Scale ranged from 0 cm (very bad) to 10 cm (very good).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale of Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.54', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '2.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'visual analog scale of performance was used for evaluation of subjective performance quality. Scale ranged from 0 cm (very bad) to 10 cm (very good).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale of Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.60', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '6.60', 'spread': '2.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Alliance Sleep Questionnaire (ASQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'OG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'self-reported information related to sleep', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers (Topper Deluxe 3.5, TEMPUR-SEALY Japan Ltd., Kobe, Japan) placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'FG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers (airweave® toppers, airweave inc., Tokyo, Japan) placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from individuals who were scheduled for an overnight PSG study as part of their regular care at the Stanford Sleep clinic.', 'preAssignmentDetails': '4 participants were enrolled but not randomized to a study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Rebound Mattress Toppers', 'description': 'Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'BG001', 'title': 'High Rebound Mattress Toppers', 'description': 'Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.42', 'spread': '15.84', 'groupId': 'BG000'}, {'value': '41.27', 'spread': '15.93', 'groupId': 'BG001'}, {'value': '40.28', 'spread': '15.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age was collected through online form, and not all participants entered age information.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White/Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Participant indicated Multiple and Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.22', 'spread': '5.61', 'groupId': 'BG000'}, {'value': '26.34', 'spread': '5.41', 'groupId': 'BG001'}, {'value': '26.30', 'spread': '5.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Room temperature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '430', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20.84', 'spread': '1.41', 'groupId': 'BG000'}, {'value': '20.88', 'spread': '1.42', 'groupId': 'BG001'}, {'value': '20.84', 'spread': '1.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Room temperature was not recorded for all participants.'}], 'populationDescription': 'Randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-04', 'size': 123834, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-15T17:28', 'hasProtocol': True}, {'date': '2020-10-13', 'size': 113293, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-15T17:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 558}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2015-08-26', 'resultsFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-15', 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Sleep Time', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)'}, {'measure': 'Sleep Efficiency Assessed by Polysomnography (PSG)', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': "Sleep efficiency is total sleep time divided by time in bed. All data were collected through the PSG data that were retrieved from the patients' medical records after completion of the recordings and analysis by the sleep technologists."}, {'measure': 'Sleep Latency Assessed by PSG', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'The amount of time from lights off to falling asleep.'}, {'measure': 'Wake After Sleep Onset (WASO) Assessed by PSG', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'Total amount of minutes awake after the first sleep epoch.'}, {'measure': 'Percentage of Time in Bed During Each Sleep Stage', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)'}, {'measure': 'Position Changes Assessed by PSG', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'Number of times participant changed position during the sleep recording.'}, {'measure': 'Apnea Hypopnea Index Assessed by PSG', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'The number of apneas or hypopneas recorded during the study per hour of sleep.'}, {'measure': 'Heart Rate', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)'}, {'measure': 'Periodic Leg Movements (PLM) During Sleep', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'Number of times participant had periodic leg movements during the sleep recording'}, {'measure': 'Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'EEG data collected from the electrode in position C2'}], 'secondaryOutcomes': [{'measure': 'Core Body Temperature', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'Difference in core body temperature changes of the high and low rebound mattress toppers at sleep onset and during sleep. The core body temperature will be monitored every minute throughout the night.'}, {'measure': 'Visual Analog Scale of Sleep', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'visual analog scale of sleep was used for evaluation of subjective sleep quality. Scale ranged from 0 cm (very bad) to 10 cm (very good).'}, {'measure': 'Visual Analog Scale of Performance', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'visual analog scale of performance was used for evaluation of subjective performance quality. Scale ranged from 0 cm (very bad) to 10 cm (very good).'}, {'measure': 'Visual Analog Scale of Mood', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good).'}, {'measure': 'Alliance Sleep Questionnaire (ASQ)', 'timeFrame': 'Overnight study visit (up to approximately 10hrs)', 'description': 'self-reported information related to sleep'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Sleep Apnea', 'Insomnia', 'sleep disorders', 'sleep environment', 'core body temperature'], 'conditions': ['Sleep Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e., airweave®) on sleep and sleep-related symptoms.\n\nThe study will compare effects of use of high rebound mattress toppers versus use of low rebound mattress toppers on sleep and sleep related symptoms and core body temperature during diagnostic sleep studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults Age 18-65 who are scheduled for a diagnostic sleep study at the Stanford Sleep Clinic for sleep disorders (including but not limited to, insomnia, Sleep Apnea or other sleep disorder symptoms).\n\nExclusion Criteria:\n\n* Individuals with a history of having difficulty swallowing food or large capsules. We will not be able to enroll individuals with any known or suspected obstructive disease of the gastrointestinal tract including, but not limited to esophageal stricture, diverticulosis and inflammatory bowel disease (IBD), peptic ulcer disease, Crohn's disease, ulcerative colitis, previous gastrointestinal surgery.\n* Individuals who are pregnant.\n* Individuals who are unable to provide informed consent (i.e. decisionally impaired)."}, 'identificationModule': {'nctId': 'NCT03055156', 'briefTitle': 'Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms', 'orgStudyIdInfo': {'id': 'IRB-34797'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low rebound mattress toppers', 'description': 'sleep with mattress topper during overnight diagnostic sleep study', 'interventionNames': ['Device: Low rebound mattress toppers']}, {'type': 'EXPERIMENTAL', 'label': 'High rebound mattress toppers', 'description': 'sleep with mattress topper during overnight diagnostic sleep study', 'interventionNames': ['Device: High rebound mattress toppers']}], 'interventions': [{'name': 'Low rebound mattress toppers', 'type': 'DEVICE', 'otherNames': ['TEMPUR-Topper Supreme'], 'description': 'Patients will sleep on this mattress topper during their diagnostic sleep study.', 'armGroupLabels': ['Low rebound mattress toppers']}, {'name': 'High rebound mattress toppers', 'type': 'DEVICE', 'otherNames': ['airweave® mattress topper'], 'description': 'Patients will sleep on this mattress topper during their diagnostic sleep study.', 'armGroupLabels': ['High rebound mattress toppers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Sleep Research Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Seiji Nishino, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Airweave Pte Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Psychiatry and Behavioral Sciences, Stanford University School of Medicine', 'investigatorFullName': 'Seiji Nishino', 'investigatorAffiliation': 'Stanford University'}}}}