Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT06141967
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2023-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patients real positive for each screening technique', 'timeFrame': 'Day 2', 'description': 'Percentage of patients real positive for each screening technique: BERLIN and EPWORTH score and Withings Sleep Analyzer addressed for polysomnography'}], 'secondaryOutcomes': [{'measure': 'Number of tests', 'timeFrame': 'Day 2', 'description': 'Number of positive tests / Number of analyzable test for screening for each type of test'}, {'measure': "Patient's experience with the use of Withings Sleep Analyzer", 'timeFrame': 'Day 2', 'description': "Patients' experience is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all."}, {'measure': "Nurse's satisfaction with the use of Withings Sleep Analyzer", 'timeFrame': '3 months', 'description': "Nurse's satisfaction is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Apnea Syndromes', 'Diabetes', 'Withings Sleep analyzer', 'Epworth', 'Berlin'], 'conditions': ['Sleep Apnea Syndromes', 'Metabolic Syndrome', 'Diabetes', 'Obese']}, 'descriptionModule': {'briefSummary': 'Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive Airway Pressure (CPAP). In this sub-population of patients, only between 40% and 50% benefit from CPAP.', 'detailedDescription': 'There is therefore an under-referral of diabetic patients to treatment, perhaps linked to the way care is organized, which clogs up the circuit and slows down or even prevents access to care. The investigators would like to test a new organization of care to facilitate and intensify this screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients over 18 years old\n* Diabetes Mellitus (Type 1 or 2), or obesity (BMI\\>30kg/m²) or metabolic syndrome\n* Hospitalized for at least one night in the Endocrinology department\n* Affiliated or entitled to a social security scheme\n* Having received informed information about the study and having co-signed, with the investigator, the informed consent form for participation in the study\n\nExclusion Criteria:\n\n* Known and/or treated OSAS-type respiratory pathology\n* No signature of the informed consent form\n* Minor or adult patients under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT06141967', 'acronym': 'AMELIAS', 'briefTitle': 'Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment', 'orgStudyIdInfo': {'id': '23CH133'}, 'secondaryIdInfos': [{'id': 'ANSM', 'type': 'OTHER', 'domain': '2023-A01288-37'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WITHINGS Sleep Analyzer', 'description': 'The sleep apnea screening device used is a medical screening device WITHINGS Sleep Analyzer (WSA)', 'interventionNames': ['Device: WITHINGS Sleep Analyzer']}], 'interventions': [{'name': 'WITHINGS Sleep Analyzer', 'type': 'DEVICE', 'otherNames': ['WSA'], 'description': 'Potentially eligible patients will be offered to participate in the study, the information leaflet will be given to them and the informed consent form will be signed if the patient agrees to participate in the study.\n\nIn hospitalization in Endocrinology:\n\n* Realization of the current care report\n* Including systematic achievement of EPWORTH and BERLIN scores\n* Activation of the WSA throughout the duration of the hospitalization\n* Completion of a feasibility questionnaire for the team\n* Quantification of the non-usable screening technique\n* Completion of a patient experience questionnaire at the end of the stay\n* In the event of published positive criteria either for the BERLIN questionnaires, EPWORTH questionnaires or WSA, the patient will be referred to the VISAS center for definitive diagnostic evaluation by polygraphy or polysomnography.', 'armGroupLabels': ['WITHINGS Sleep Analyzer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Natacha GERMAIN, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}