Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01354756
Status:
TERMINATED
Last Update Posted:
2015-03-10
First Post:
2011-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'device was stolen', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2011-05-06', 'studyFirstSubmitQcDate': '2011-05-16', 'lastUpdatePostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with correct diagnosis of OSA with ApneaLink. Therefore, we will compare apnea-hypopnea index measured with ApneaLink with apnea-hypopnea index measured during polysomnography.', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep apnea', 'polysomnography', 'obesity', 'bariatric surgery'], 'conditions': ['Sleep Apnea Syndrome']}, 'descriptionModule': {'briefSummary': 'Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric surgery. There is a need for alternative screening tools for sleep apnea detection in the pre-operative period. The investigators would like to compare ApneaLink and complete polysomnography in this population.', 'detailedDescription': 'OSA can occur in up to 78% of patients undergoing bariatric surgery(1). Moderate to severe case will benefit from CPAP therapy, that can help avoiding post-operative complications(2).\n\nIn this population, the investigators propose complete attended in-hospital polysomnography (PSG)in patients with a clinical high probability of OSA.\n\nAccording to obesity epidemics (3), waiting list for PSG in sleep labs is every day longer.\n\nThe investigators want to assess sensitivity and specificity of a new portable screening tool, ApneaLink, to detect OSA in a bariatric population.\n\nDesign:\n\nmonocentric and prospective study\n\nMethods:\n\nPatients:\n\n\\- OSA suspicion based on :\n\n* symptoms and signs (snoring, apneas , neck circumference \\>38 (women) or 43cm (men))\n* BMI \\> 50\n* BMI \\> 40, \\> 40 y\n* BMI \\> 35, men, hypertension\n* increased serum Bicarbonate\n* Polyglobulia\n\nMeasurements\n\n* Polysomnography in sleep lab with concommitant recording performed with Apnea LinkTM (nasal flow and oxymétry recording).\n* between 2 weeks : recording performed with Apnea LinkTM (nasal flow and oxymétry recording)at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'obese patients, \\> 18y old, in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese patients\n* \\> 18 years old\n* in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening\n\nExclusion Criteria:\n\n* pulmonary, neurologic, neuromuscular disease\n* \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT01354756', 'briefTitle': 'Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population', 'orgStudyIdInfo': {'id': 'AK/10-09-3921/52'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bariatric population', 'description': 'obese patients in whom a bariatric surgery is planified'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marie Bruyneel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU St Pierre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chef de Clinique', 'investigatorFullName': 'Marie Bruyneel', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Saint Pierre'}}}}