Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-28 @ 3:52 AM
Study NCT ID:
NCT04759157
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2021-02-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
We-PAP: A Couples-based Intervention for Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kelly.baron@utah.edu', 'phone': '801-585-7588', 'title': 'Dr. Kelly Baron', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations include: small sample size, enrollment at a single academic sleep center, primarily White sample with high educational attainment.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'Adverse reports were collected if reported by the participants in intervention sessions or assessment visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Couples-based Treatment- Patient', 'description': 'Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Couples-based Treatment- Partner', 'description': 'Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Standard Information Control- Patient', 'description': 'Standardized education: Patients will receive standardized educational materials plus one phone call', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Standard Information Control- Partner', 'description': 'Standardized education: Patients will receive standardized educational materials plus one phone call', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recruitment Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients', 'description': 'Patients recently diagnosed with obstructive sleep apnea (pre-randomization)'}, {'id': 'OG001', 'title': 'Partners', 'description': 'Partners of patients recently diagnosed with obstructive sleep apnea (OSA), pre-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'study duration', 'description': 'Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period (12 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With PAP Use of 4 Hours or More', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Couples-based Treatment- Patient', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'OG001', 'title': 'Standard Information Control- Patient', 'description': 'Participants will receive treatment as usual and also standardized information about OSA and CPAP.\n\nStandardized education: Patients will receive standardized educational materials'}], 'classes': [{'categories': [{'measurements': [{'value': '.73', 'spread': '.08', 'groupId': 'OG000'}, {'value': '.72', 'spread': '.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.30', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': "The primary efficacy measure for this pilot trial was the percentage of days that patients used CPAP for 4 hours or more over the first 3 months. This 4 hour cutoff was selected becasue it is the minimum usage defined by Medicare and other insurance companies. We obtained patients' CPAP usage by downloading data from their machine using a remote dashboard. Data are only available for patients because partners were not using the treatment. This variable is defined as a proportion, calculated as the number of days with CPAP usage of 4 hours or more divided by the total number of days collected in the 3 month recording period. Scores can range from 0 (no days with use to 1, indicating all days with use of 4 hours or more).", 'unitOfMeasure': 'proportion of nights with CPAP >=4h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had their PAP machine removed were given a zero at 3 months (n=2 patients)'}, {'type': 'SECONDARY', 'title': 'Self-reported Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Couples-based Treatment- Patient', 'description': 'Couples-based sleep health intervention'}, {'id': 'OG001', 'title': 'Couples-based Treatment- Partner', 'description': 'Couples-based sleep-health intervention'}, {'id': 'OG002', 'title': 'Standard Information Control- Patient', 'description': 'Information plus one follow-up phone call'}, {'id': 'OG003', 'title': 'Standard Information Control- Partner', 'description': 'Information plus one follow-up phone call'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55.3', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '56.7', 'spread': '7.8', 'groupId': 'OG002'}, {'value': '48.6', 'spread': '6.4', 'groupId': 'OG003'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49.6', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '48.3', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '51', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '48.7', 'spread': '6.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.206', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-6.63', 'ciUpperLimit': '1.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.05', 'estimateComment': 'This estimate is comparing intervention to control from baseline to 3 month for both patients and partners', 'groupDescription': 'We conducted multilevel models evaluating sleep disturbance score by assessment, group and patient versus partner status.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Patient sleep quality on the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scale, 8 item, version 8b. Models evaluated change from baseline to 3 months. Raw are converted to t-scores, with a range of 28.9-76.5, a mean of 50 and a SD of 10. Higher scores indicate poorer sleep subjective quality.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline PROMIS sleep quality data are missing for this variable for one couple in the intervention group and one couple in the control group'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intervention Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Couples-based Treatment- Patient', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'OG001', 'title': 'Couples Based Treatment- Partner', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'OG002', 'title': 'Information Control- Patient', 'description': 'Treatment as usual plus standardized educational materials'}, {'id': 'OG003', 'title': 'Information Control- Partner', 'description': 'Treatment as usual plus standardized educational materials'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'intervention period, 1 month', 'description': 'Percentage of participants who completed the intervention sessions: 3 sessions for the couples-based treatment group and 1 handout and phone call for the information control group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '100% of participants completed the planned intervention for their assigned group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Couples-based Treatment- Patient', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'OG001', 'title': 'Couples Based Treatment- Partner', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'OG002', 'title': 'Information Control- Patient', 'description': 'Treatment as usual plus standardized educational materials'}, {'id': 'OG003', 'title': 'Information Control- Partner', 'description': 'Treatment as usual plus standardized educational materials'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We acheived 100% retention, with all participants completing the 3 month follow-up assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Couples-based Treatment- Patient', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'FG001', 'title': 'Couples Based Treatment- Partner', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'FG002', 'title': 'Information Control- Patient', 'description': 'Treatment as usual plus standardized educational materials'}, {'id': 'FG003', 'title': 'Information Control- Partner', 'description': 'Treatment as usual plus standardized educational materials'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from June 2021 to October 2023 from the University of Utah Sleep Wake Center among patients who were undergoing sleep apnea testing (polysomnography and home sleep testing) for suspected sleep apnea.\n\n84 participants were consented and 74 continued to baseline assessment. A total of 10 individuals (5 couples) did not complete baseline for the following reason: 4 couples became ineligible (did not start PAP, started oxygen), 1 couple did not complete baseline.', 'preAssignmentDetails': 'Participants were recruited if they were planning to begin PAP treatment for obstructive sleep apnea.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Couples-based Treatment- Patient', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'BG001', 'title': 'Couples-based Treatment- Partner', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.\n\nCouples-based treatment: Couples will attend 3, video based sessions for couples-based treatment'}, {'id': 'BG002', 'title': 'Standard Information Control- Patient', 'description': 'Participants will receive treatment as usual and also standardized information about OSA and CPAP.\n\nStandardized education: Patients will receive standardized educational materials'}, {'id': 'BG003', 'title': 'Standard Information Control- Partner', 'description': 'Participants will receive treatment as usual and also standardized information about OSA and CPAP.\n\nStandardized education: Patients will receive standardized educational materials'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '66.1', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '64.3', 'spread': '11.6', 'groupId': 'BG003'}, {'value': '63.2', 'spread': '8.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '84 individuals (42 couples) initially consented and 74 individuals (37) completed baseline assessments. A total of 10 participants (5 couples) were removed or declined to continue to baseline (4 couples became inelgibile and 1 declined)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-09', 'size': 159575, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-02T17:40', 'hasProtocol': True}, {'date': '2020-03-12', 'size': 173769, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-02T17:31', 'hasProtocol': False}, {'date': '2021-03-29', 'size': 290656, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-02T17:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators and outcomes assessors will not have knowledge of the randomization table. Participants will be reminded to not to tell the outcomes assessors their group. Only the statistician and interventionist will be aware of the group.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a dyadic study. Couples are randomly assigned as a dyad.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2021-02-13', 'resultsFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2021-02-13', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-06', 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intervention Completion', 'timeFrame': 'intervention period, 1 month', 'description': 'Percentage of participants who completed the intervention sessions: 3 sessions for the couples-based treatment group and 1 handout and phone call for the information control group'}, {'measure': 'Retention', 'timeFrame': '3 months', 'description': 'We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.'}], 'primaryOutcomes': [{'measure': 'Recruitment Feasibility', 'timeFrame': 'study duration', 'description': 'Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period (12 months)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Days With PAP Use of 4 Hours or More', 'timeFrame': '3 months', 'description': "The primary efficacy measure for this pilot trial was the percentage of days that patients used CPAP for 4 hours or more over the first 3 months. This 4 hour cutoff was selected becasue it is the minimum usage defined by Medicare and other insurance companies. We obtained patients' CPAP usage by downloading data from their machine using a remote dashboard. Data are only available for patients because partners were not using the treatment. This variable is defined as a proportion, calculated as the number of days with CPAP usage of 4 hours or more divided by the total number of days collected in the 3 month recording period. Scores can range from 0 (no days with use to 1, indicating all days with use of 4 hours or more)."}, {'measure': 'Self-reported Sleep Disturbance', 'timeFrame': '3 months', 'description': 'Patient sleep quality on the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scale, 8 item, version 8b. Models evaluated change from baseline to 3 months. Raw are converted to t-scores, with a range of 28.9-76.5, a mean of 50 and a SD of 10. Higher scores indicate poorer sleep subjective quality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OSA'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '35933417', 'type': 'DERIVED', 'citation': 'Baron KG, Gilles A, Sundar KM, Baucom BRW, Duff K, Troxel W. Rationale and study protocol for We-PAP: a randomized pilot/feasibility trial of a couples-based intervention to promote PAP adherence and sleep health compared to an educational control. Pilot Feasibility Stud. 2022 Aug 6;8(1):171. doi: 10.1186/s40814-022-01089-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop, refine and evaluate the feasibility of a novel couples-based intervention to improve adherence for patients with obstructive sleep apnea (OSA).', 'detailedDescription': 'This study will develop and test a novel couples-based intervention for the treatment of OSA and sleep health among older couples. The focus of this study is patient who are starting CPAP treatment and their partners. Couples will be randomized to a 3-session sleep health intervention delivered via telehealth or to standard educational support for CPAP. The intervention is based on a transdiagnostic model of sleep and circadian disorders (TransS-C) and rooted in the idea that older adults with OSA are often also having other sleep problems, and that OSA is best treated in the couples context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient and partner inclusion criteria:\n\n1. Age \\>=50\n2. Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention.\n\nPatients inclusion criteria:\n\n1. Diagnosed with OSA (AHI\\>10 or AHI\\>5 with impairment) and intend to start PAP treatment\n2. PAP naïve or non-use of PAP for at least 3 years\n3. Married or cohabiting with a romantic partner for \\>1 year\n4. Able to read/write English.\n\nPartner inclusion criteria:\n\n1. Able to read/write English\n2. PROMIS sleep disturbance score \\>55 in either patient or partner, or desire to improve sleep.\n\nExclusion Criteria:\n\nPatient only exclusion criteria:\n\n1\\. Concomitant OSA treatments (bariatric surgery planned in the next 3 months or bariatric surgery in the past year, ear nose and throat surgery for sleep apnea occurring in the 3 months before or planning for within the study period).\n\nExclusion criteria for both patient and partner include the following:\n\n1. High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)\n2. History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis)\n3. Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse reported on the Audit-C (score \\>4 for men, \\>3 for women), drug use (NIDA-Modified ASSIST score \\>3)\n4. Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD)\n5. Use of ASV, VPAP or supplemental oxygen\n6. Overnight work \\> 1x per month\n7. Pregnancy/ desire to become pregnant in the study period\n8. Current participation in behavioral sleep treatment (e.g., CBT-I) or completion of CBT-I in the past 3 years\n9. Concurrent participation in another clinical trial\n10. Caregiving for an infant \\< 2 years old or adult who requires overnight assistance."}, 'identificationModule': {'nctId': 'NCT04759157', 'acronym': 'We-PAP', 'briefTitle': 'We-PAP: A Couples-based Intervention for Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': "A Novel Couples- Based Sleep Health Intervention For Older Adults With Obstructive Sleep Apnea: Implications for Alzheimer's Disease Risk And Healthy Aging", 'orgStudyIdInfo': {'id': '00135927'}, 'secondaryIdInfos': [{'id': '1R21AG067183-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21AG067183-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Couples-based treatment- Patient', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.', 'interventionNames': ['Behavioral: Couples-based treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Couples-based treatment- Partner', 'description': 'Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.', 'interventionNames': ['Behavioral: Couples-based treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Information Control- Patient', 'description': 'Participants will receive treatment as usual and also standardized information about OSA and CPAP.', 'interventionNames': ['Other: Standardized education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Information Control- Partner', 'description': 'Participants will receive treatment as usual and also standardized information about OSA and CPAP.', 'interventionNames': ['Other: Standardized education']}], 'interventions': [{'name': 'Couples-based treatment', 'type': 'BEHAVIORAL', 'description': 'Couples will attend 3, video based sessions for couples-based treatment', 'armGroupLabels': ['Couples-based treatment- Partner', 'Couples-based treatment- Patient']}, {'name': 'Standardized education', 'type': 'OTHER', 'description': 'Patients will receive standardized educational materials', 'armGroupLabels': ['Information Control- Partner', 'Information Control- Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Within 1 year of completion of the study, will be available for 3 years.', 'ipdSharing': 'YES', 'description': 'Data will be made available upon request', 'accessCriteria': 'Written request to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'RAND', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kelly Glazer Baron', 'investigatorAffiliation': 'University of Utah'}}}}