Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 6:02 PM
Study NCT ID:
NCT04326634
Status:
UNKNOWN
Last Update Posted:
2020-03-30
First Post:
2020-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Exercises Effectiveness in Patients With 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'awake episodes', 'timeFrame': 'immediately after treatment', 'description': 'number of awake episodes'}, {'measure': 'awake episodes', 'timeFrame': '3 months', 'description': 'number of awake episodes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apnea, Sleep']}, 'descriptionModule': {'briefSummary': 'The aim is to compare a programme of controlled exercises therapy vs a programme of non controlled exercises therapy in patients with sleep apnea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sleep apnea\n\nExclusion Criteria:\n\n* neurologic disease'}, 'identificationModule': {'nctId': 'NCT04326634', 'briefTitle': 'Controlled Exercises Effectiveness in Patients With Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Controlled Exercises Effectiveness in Patients With Sleep Apnea', 'orgStudyIdInfo': {'id': 'Geserher'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Controlled exercises Group', 'interventionNames': ['Other: controlled exercises', 'Other: non controlled exercises group']}, {'type': 'EXPERIMENTAL', 'label': 'Non controlled exercises Group', 'interventionNames': ['Other: controlled exercises', 'Other: non controlled exercises group']}], 'interventions': [{'name': 'controlled exercises', 'type': 'OTHER', 'description': 'controlled exercises', 'armGroupLabels': ['Controlled exercises Group', 'Non controlled exercises Group']}, {'name': 'non controlled exercises group', 'type': 'OTHER', 'description': 'non controlled exercises', 'armGroupLabels': ['Controlled exercises Group', 'Non controlled exercises Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gema Serrano-Hernanz, PhD', 'role': 'CONTACT', 'email': 'gema.serrano.hernanz@gmail.com', 'phone': '669332986'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Gema Serrano-Hernanz', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}