Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-01 @ 9:46 AM
Study NCT ID:
NCT01678560
Status:
TERMINATED
Last Update Posted:
2019-12-11
First Post:
2012-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Remote Monitoring in Obstructive 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': 'meir.kryger@yale.edu', 'phone': '203-815-0914', 'title': 'Meir Kryger, MD', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'CPAP was outsourced eliminating the point of recruitment which halted limiting the study proceeded to the follow-up of recruited patients. Planned statistical data analysis was not performed due to the smaller then expected numbers (expected 220)'}}, 'adverseEventsModule': {'timeFrame': "Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study", 'description': "The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions.\n\nData was collected during the subject's follow-up and from the medical chart review.", 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.\n\nMonitoring every 3 months by face-to-face visits', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Wireless Care', 'description': 'These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.\n\nFrequent remote monitoring', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Acute Inpatient Psychiatric hospitalization', 'notes': 'Patient has long history of depression and anxiety. Patient stated his anxiety and depression has increased. Pt. Not suicidal, no hallucinations. Discharged in 3 days.Has outpatient psychiatric services.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wolf -Parkinson-White syndrome. Hospitalization', 'notes': 'Patient with WPW syndrome (Wolff-Parkinson-White syndrome) and previous ablation was hospitalized for sotabol load and discharged from to home in 3 days after achieving the goals of hospitalization with no restriction to physical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalisation due to Dyspnea and Chest Pain on exertion', 'notes': 'A patient with a history of Myocardial Infarction presented with Dyspnea and Chest Pain on exertion. Troponins negative. Underwent nuclear stress test showed normal myocardial perfusion. Discharged home in 3 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization of encephalopathic patient transitioned to comfort care', 'notes': 'Participant with underlying cirrhosis of the liver, lung mass (possible cancer) and hepatocellular carcinoma was taken to a local civilian hospital. He was profoundly encephalopathic and transitioned to comfort care. Reported in mortality section.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Elective Laparoscopic repair of incisional hernia', 'notes': 'Laparoscopic repair of incisional hernia complicated by post op ileus. Discharged in 9 days with scheduled follow up', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for Elective Laminectomy - Fusion', 'notes': 'Hospitalization for Elective Laminectomy - Fusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.\n\nMonitoring every 3 months by face-to-face visits'}, {'id': 'OG001', 'title': 'Wireless Care', 'description': 'These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.\n\nFrequent remote monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fisher exact test statistic value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1', 'pValueComment': 'Hypothesis: Active continuous monitoring of PAP treatment in OSA will result in improved adherence at 90 days Exact Fisher test was used on the collected information from the limited population.', 'groupDescription': 'PAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department. The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Exact Fisher test was used on the information from the limited population.', 'nonInferiorityComment': 'Exact Fisher test was used on the collected information from the limited population', 'otherAnalysisDescription': 'Exact Fisher test was used on the collected information from the limited population.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First 3 months', 'description': 'Positive Airway Pressure Treatment Adherence defined as mean PAP use being \\> 4 hours per night for greater than 70% of nights.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.\n\nMonitoring every 3 months by face-to-face visits'}, {'id': 'OG001', 'title': 'Wireless Care', 'description': 'These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.\n\nFrequent remote monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fisher exact test statistic value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1', 'pValueComment': 'Hypothesis: Active continuous monitoring of PAP treatment in OSA (Wireless group) will result in improved adherence at 90 days compared to Usual Group.\n\nExact Fisher test was used on the collected information from the limited population.', 'groupDescription': 'CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Exact Fisher test was used on the information from the limited population', 'nonInferiorityComment': 'Exact Fisher test was used on the collected information from the limited population', 'otherAnalysisDescription': 'Exact Fisher test was used on the collected information from the limited population'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-12 Months', 'description': 'Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being \\> 4 hours per night for greater than 70% of nights', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Receiving Effective Treatment for Obstructive Sleep Apnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.\n\nMonitoring every 3 months by face-to-face visits'}, {'id': 'OG001', 'title': 'Wireless Care', 'description': 'These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.\n\nFrequent remote monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimation Parameter Other[Fisher exact', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1', 'pValueComment': 'Hypothesis - Number of patients effectively treated with the PAP will be higher in the Wireless Group compared to the Usual Group Exact Fisher test was used on the collected information from the limited population.', 'groupDescription': 'CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Exact Fisher test was used on the collected information from the limited population'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject from the Wireless group was assigned to Provent treatment. 1 subject from the Usual group was assigned to Dental device treatment. Both subjects stopped using PAP and PAP monitoring and were considered not receiving effective PAP treatment for obstructive sleep apnea. Both subjects were lost in follow-up for our research study.'}, {'type': 'POST_HOC', 'title': 'PAP Treatment Adherence in the First 3 Months of Treatment Compared to the PAP Treatment Adherence in the Next 9 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initially Adherent Subjects', 'description': 'Subjects who became Adherent to the PAP treatment according to the CMS criteria within the first 3 months of treatment'}, {'id': 'OG001', 'title': 'Initially Non-Adherent Subjects', 'description': 'Subjects who remained Non-Adherent to the PAP treatment according to the CMS criteria within the first 3 months of treatment'}], 'classes': [{'categories': [{'title': 'Adherent in the next 9 months', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Non-Adherent in the next 9 months', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Other[Fisher exact test statistic value]', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0286', 'pValueComment': 'Hypothesis - PAP treatment Adherence in the first 3 months of treatment predicts the PAP treatment Adherence in the next 9 months of treatment Exact Fisher test was used on the collected information from the limited population', 'estimateComment': 'Exact Fisher test was used on the collected information from the limited population.', 'groupDescription': 'Exact Fisher test was used on the collected information from the limited population', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Exact Fisher test was used on the collected information from the limited population', 'otherAnalysisDescription': 'Exact Fisher test was used on the collected information from the limited population.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'PAP treatment Adherence in the first 3 months of treatment (according to the CMS - Centers for Medicare \\& Medicaid Services - criteria) was compared to the PAP treatment Adherence in the next 9 months of treatment to verify the predictability of initial adherence or non-adherence for the future adherence or non-adherence (during the year) to PAP treatment. Adherence/non-adherence was analyzed based on the PAP usage reports (downloads) from the supplied PAP device, based on the yearly, quarterly and monthly portions of the reports.\n\nPatient data representing initial adherence or non-adherence and adherence or non-adherence during the year to PAP treatment was collected across both Usual care and Wireless Care Arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Adherence and AHI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AHI More Than 20', 'description': 'subjects who had more than 20 respiratory events per hour during the initial sleep study'}, {'id': 'OG001', 'title': 'AHI Less Than 20', 'description': 'subjects who had less than 20 respiratory events per hour during the initial sleep study'}], 'classes': [{'categories': [{'title': 'Adherent in 12 months', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'ANon-Adherent in 12 months', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Exact Fisher test', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0039', 'pValueComment': 'Hypothesis: Patients with the higher AHI are more likely to become adherent to the PAP therapy.\n\nExact Fisher test was used on the collected information from the limited population', 'groupDescription': 'Exact Fisher test was used on the collected information from the limited population', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Exact Fisher test was used on the collected information from the limited population', 'nonInferiorityComment': 'Exact Fisher test was used on the collected information from the limited population', 'otherAnalysisDescription': 'Exact Fisher test was used on the collected information from the limited population'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year/12 months', 'description': 'PAP adherence in subjects who had more than 20 respiratory events per hour during the initial sleep study was compared with the PAP adherence in subjects who had less than 20 respiratory events per hour during the initial sleep study.Patient data representing subjects who had more than 20 respiratory events per hour during the initial sleep study and subjects who had less than 20 respiratory events per hour during the initial sleep study was collected across both Usual care and Wireless Care Arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.\n\nMonitoring every 3 months by face-to-face visits'}, {'id': 'FG001', 'title': 'Wireless Care', 'description': 'These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.\n\nFrequent remote monitoring'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.\n\nMonitoring every 3 months by face-to-face visits'}, {'id': 'BG001', 'title': 'Wireless Care', 'description': 'These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.\n\nFrequent remote monitoring'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'Recruitment was halted due to the difficulties in recruiting.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-10', 'studyFirstSubmitDate': '2012-08-30', 'resultsFirstSubmitDate': '2018-09-04', 'studyFirstSubmitQcDate': '2012-09-04', 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-10', 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months', 'timeFrame': 'First 3 months', 'description': 'Positive Airway Pressure Treatment Adherence defined as mean PAP use being \\> 4 hours per night for greater than 70% of nights.'}, {'measure': 'Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months', 'timeFrame': '4-12 Months', 'description': 'Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being \\> 4 hours per night for greater than 70% of nights'}], 'secondaryOutcomes': [{'measure': 'Receiving Effective Treatment for Obstructive Sleep Apnea', 'timeFrame': '12 months', 'description': 'Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obstructive sleep apnea PAP adherence efficacy economics'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '30736874', 'type': 'DERIVED', 'citation': 'Naik S, Al-Halawani M, Kreinin I, Kryger M. Centers for Medicare and Medicaid Services Positive Airway Pressure Adherence Criteria May Limit Treatment to Many Medicare Beneficiaries. J Clin Sleep Med. 2019 Feb 15;15(2):245-251. doi: 10.5664/jcsm.7626.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to the patient in terms of serious co-morbidities and results in a great cost to the VA Health Care System to treat the co-morbidities, which include heart disease, stroke and neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and studies have shown a poor adherence to treatment. The investigators hypothesize that using wireless technology will lead to early detection of problems of treatment use and will translate into early remedial action which will improve the use and effectiveness of treatment. The investigators will compare two methods. Usual care involves downloading data from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit. Wireless care involved more frequent monitoring and intervention in the event of anomalies in treatment use or effectiveness.', 'detailedDescription': "Prior to enrollment, patients were seen by a clinician at the Veterans Administration (VA) Hospital in West Haven, Connecticut. Either a facility-based diagnostic polysomnogram or unattended home sleep testing was performed at the evaluating clinician's discretion. Clinicians that saw the patient determined whether PAP therapy was needed, and either auto-titrating continuous positive airway pressure (CPAP) or set pressures of CPAP were ordered for the patient. Patients received education about OSA and about their equipment from a respiratory therapist and physician's assistant within the VA who then provided the equipment for them. Patients coming to this internal Durable Medical Equipment (DME) provider were screened for participation in the study.The study was overseen by the Institutional Review Board at the Veterans Affairs Connecticut Health Care in West Haven, Connecticut. Informed consent was obtained from all participants.\n\nPatients were included in the study if they were diagnosed with OSA (defined as AHI or apnea-hypopnea index greater than five per hour with symptoms, or AHI greater than 15/hour), and if they were being exposed to PAP for the first time. Patients who were previously treated with PAP, had central apnea, chronic respiratory failure, recent in-patient hospital admissions (=\\< 2 weeks), or were living outside cellular network coverage area were excluded from the study.\n\nPatients that met study inclusion criteria were provided ResMed S9 devices with wireless modems. Their usage and treatment data was tracked using EasyCare Online, a cloud-based system for the ResMed devices. After the initial setup and educational settings, the patients received supplies as needed and troubleshooting of side effects of treatment as needed. Devices were not removed after 3 months if they were not adherent.\n\nPatients in the usual care group were monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data were only assessed by the clinician at these intervals.\n\nPatients in the wireless care group were monitored more frequently using wireless modems as the method to obtain adherence and efficacy data.\n\nWe then determined adherence using CMS (Centers for Medicare \\& Medicaid Services) criteria at 3 months, and at 12 months. To obtain this data, we evaluated whether the PAP devices were used for 4 or more hours per night on 70% of nights during a consecutive 30-day period anytime during the first 3 months of initial use, and then a consecutive 30-day period in months 4-12. We also examined the daily use from the first to last day looking of overall patterns of utilization monthly, quarterly, semiannually and annually. Data was collected and maintained in a REDCap database (REDCap is a secure web application for building and managing online surveys and databases). Sensitivity and specificity calculations were then performed to evaluate predictability of adherence at 1 year using adherence at 3 months. Fisher's exact test was also used to evaluate the association between adherence at 3 months and 1 year and the association between AHI (Apnea -Hypopnea Index) and adherence."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed OSA patients\n* AHI of 5/hour or greater\n* Prescribed CPAP therapy\n* Able to comply with treatment and understand treatment instructions\n\nExclusion Criteria:\n\n* Not able to understand study requirements\n* Significant cardiorespiratory disease - e.g. COPD (chronic obstructive pulmonary disease), severe CHF (congestive heart failure)\n* Clinical instability at time of apnea diagnosis\n* Prescribed BiPap (bilevel positive airway pressure) or ASV (Adaptive Support Ventilation), which are other types of PAP'}, 'identificationModule': {'nctId': 'NCT01678560', 'briefTitle': 'Remote Monitoring in Obstructive Sleep Apnea', 'organization': {'class': 'FED', 'fullName': 'VA Connecticut Healthcare System'}, 'officialTitle': 'Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans', 'orgStudyIdInfo': {'id': '01648'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Monitoring every 3 months by face-to-face visits:These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.', 'interventionNames': ['Device: Monitoring every 3 months by face-to-face visits']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wireless Care', 'description': 'Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.', 'interventionNames': ['Device: Frequent remote monitoring']}], 'interventions': [{'name': 'Monitoring every 3 months by face-to-face visits', 'type': 'DEVICE', 'description': 'These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.', 'armGroupLabels': ['Usual Care']}, {'name': 'Frequent remote monitoring', 'type': 'DEVICE', 'description': 'These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls', 'armGroupLabels': ['Wireless Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Health System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Meir Kryger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Connecticut Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Connecticut Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}