Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-26 @ 10:34 PM
Study NCT ID:
NCT03537066
Status:
TERMINATED
Last Update Posted:
2022-05-24
First Post:
2018-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CALLSAS Study: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'inability to include subjects on schedule', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of CPAP on phone usage habits indices', 'timeFrame': 'from 6 months before CPAP treatment until 6 months after CPAP treatment initiation', 'description': 'Changes in indices of phone usage habits'}], 'secondaryOutcomes': [{'measure': 'Time course evolution of phone usage habits indices and evolution of sleepiness', 'timeFrame': 'from CPAP initiation until 6 months after CPAP treatment initiation', 'description': 'Assessment of sleepiness by ESS'}, {'measure': 'Time course evolution of phone usage habits indices and evolution of depression', 'timeFrame': 'from CPAP initiation until 6 months after CPAP treatment initiation', 'description': 'Assessment of depression by Pichot scale'}, {'measure': 'Time course evolution of phone usage habits indices and evolution of quality of life', 'timeFrame': 'from CPAP initiation until 6 months after CPAP treatment initiation', 'description': 'Assessment of quality of life by SF-36'}, {'measure': 'Time course evolution of phone usage habits indices and evolution of locomotion', 'timeFrame': 'from CPAP initiation until 6 months after CPAP treatment initiation', 'description': 'patterns of locomotion objectively measured by a gait platform'}, {'measure': 'CPAP adherence', 'timeFrame': 'from CPAP initiation until 6 months after CPAP treatment initiation', 'description': 'Time course evolution of CPAP adherence assessed by telemonitoring versus time course evolution of phone usage habits'}, {'measure': 'Access to care as a predictor of CPAP adherence', 'timeFrame': 'from CPAP initiation until 6 months after CPAP treatment initiation', 'description': 'Care access questionnaire developed by ODENORE and National French insurance'}, {'measure': 'Effect of food habit with CPAP treatment', 'timeFrame': 'At CPAP initiation and at 6 months after CPAP treatment initiation', 'description': 'Changes in food frequence questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'Continuous positive airway pressure (CPAP) treatment improves sleepiness, depression and social activities in patients with obstructive sleep apnea (OSA). This evolution can be captured from changes in phone usage habits coupled with a mobile-based services. The aim of this study is to assess the impact of CPAP treatment on phone usage habits in OSA patients.', 'detailedDescription': 'Callsas is a prospective study embarking newly diagnosed obstructive sleep apnea patients initiated to CPAP treatment.\n\nThe primary objective is to analyze the modifications in phone usage habits before and after CPAP treatment.\n\nSecondary objectives:\n\n* Correlation between changes in phone usage habits and evolution of sleepiness\n* Correlation between changes in phone usage habits and evolution of depression scale\n* Correlation between changes in phone usage habits and evolution of quality of life\n* Correlation between changes in physical activity measured by phones and evolution of physical activity objectively measured by actigraphy and gait platform\n* Correlation between phone usage habits and CPAP adherence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed OSA patients initiated on CPAP\n* Follow-up at home by AGIR à dom\n* Customers of Orange (or Sosh) for mobile and/or fixed-line telephony for at least 6 months\n* Patient who signed a written consent to participate in the study\n* Patient affiliated to social security\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients with disease not allowing to realize functional and locomotion tests\n* Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship)\n* Patient who, in the judgment of the investigator, may not be cooperative or respectful of the obligations inherent to participation in the study'}, 'identificationModule': {'nctId': 'NCT03537066', 'acronym': 'CALLSAS', 'briefTitle': 'CALLSAS Study: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits: the Callsas Study', 'orgStudyIdInfo': {'id': '2017-A02540-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CPAP treatment', 'description': 'All included OSA patients are going to be treated by CPAP', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'All patients included will be treated by CPAP', 'armGroupLabels': ['CPAP treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Grenoble Alps University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Louis PEPIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Grenoble Alpes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}