Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-06-13 @ 9:54 PM
Study NCT ID:
NCT03079466
Status:
UNKNOWN
Last Update Posted:
2017-03-14
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epworth Sleepiness Scale', 'timeFrame': '3 months', 'description': 'Measure of diurnal sleepiness'}, {'measure': 'Quebec Sleep Questionnaire domains', 'timeFrame': '3 months', 'description': 'Quality of Life measured in sleep apnea patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep apnea', 'Elderly', 'CPAP'], 'conditions': ['Unrecognized Condition']}, 'referencesModule': {'references': [{'pmid': '34915264', 'type': 'DERIVED', 'citation': 'Martinez-Garcia MA, Oscullo G, Ponce S, Pastor E, Orosa B, Catalan P, Martinez A, Hernandez L, Muriel A, Chiner E, Vigil L, Carmona C, Mayos M, Garcia-Ortega A, Gomez-Olivas JD, Beauperthuy T, Bekki A, Gozal D. Effect of continuous positive airway pressure in very elderly with moderate-to-severe obstructive sleep apnea pooled results from two multicenter randomized controlled trials. Sleep Med. 2022 Jan;89:71-77. doi: 10.1016/j.sleep.2021.11.009. Epub 2021 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'Objective: To analyze the impact of CPAP treatment on cognitive, clinical and quality of life domains in patients over 70 years of age with mild-to-moderate OSA\n\nPrimary Outcome: Epworth scale and QSQ domains\n\nSecondary Outcomes: Neurocognitive variables and CPAP adherence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age equal or greater than 70 years of both sexes\n* Patients with sleep study results with AHI ≥ 15 and \\< 30\n\nExclusion Criteria:\n\n* Alternative diagnoses of other non-respiratory sleep disorders that are also cause of pathological somnolence (eg, sdr restless legs, narcolepsy, etc.)\n* Don't sign informed consent\n* Acute or chronic respiratory insufficiency requiring home oxygen therapy\n* Patients with Obesity Hypoventilation Syndrome\n* Diagnosis of neuro-psychiatric diseases with the exception of anxiety - depression or diagnosis of dementia.\n* Diseases of any origin in the acute phase\n* Heart failure or recent stroke (less than 3 months).\n* Central SAHS (more than 50% of the registry with central apneas or Cheyne-Stokes breathing)\n* Pre-treatment with CPAP\n* Inability to perform the diagnostic study of sleep due to the patient's condition\n* Hipersomniaincapacitante (Epworth≥18) with no known or most likely cause related to SAHS"}, 'identificationModule': {'nctId': 'NCT03079466', 'briefTitle': 'Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Doctor Peset'}, 'officialTitle': 'Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea', 'orgStudyIdInfo': {'id': 'sleep workgroup'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment CPAP', 'description': 'A group treated with CPAP', 'interventionNames': ['Other: CPAP']}, {'type': 'SHAM_COMPARATOR', 'label': 'group without treatment', 'interventionNames': ['Other: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'OTHER', 'description': 'This is a randomized study where patients are included consecutively under a randomization order that will be given to the investigators. Patients will continue to be treated with CPAP and other treatment with no CPAP for a duration of 3 months and with intention-to-treat analysis And by protocol.', 'armGroupLabels': ['Treatment CPAP', 'group without treatment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Doctor Peset', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Silvia Ponce Perez', 'investigatorAffiliation': 'Hospital Universitario Doctor Peset'}}}}