[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657268":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":56,"interventions":63,"overallOfficials":48,"centralContacts":68,"locations":78,"responsibleParty":96,"collaborators":48,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":48,"enrollmentInfo":107,"targetDuration":48,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":118,"whyStopped":48,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Internal validity of PRAQ","Internal validity (consistency measured by Cronbach's alpha and exploratory and confirmatory factor analysis) of the French version of the \"Patient-Reported Apnea Questionnaire\" (PRAQ)","Between 6 and 18months after inclusion (day 0)",[14,18,21,24,27,30,33,36,39,42,45],{"measure":15,"description":16,"timeFrame":17},"Insomnia severity (Insomnia Severity Index, ISI)","Insomnia severity assessed using the Insomnia Severity Index (ISI), a 7-item patient-reported questionnaire with a total score ranging from 0 to 28. Higher scores indicate more severe insomnia symptoms (0-7: no clinically significant insomnia; 8-14: subthreshold insomnia; 15-21: moderate insomnia; 22-28: severe insomnia).","At inclusion (day 0)",{"measure":19,"description":20,"timeFrame":17},"Daytime sleepiness (Epworth Sleepiness Scale, ESS)","Daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS), an 8-item questionnaire with a total score ranging from 0 to 24. Higher scores indicate greater daytime sleepiness. Scores greater than 10 suggest excessive daytime sleepiness.",{"measure":22,"description":23,"timeFrame":17},"Anxiety and depressive symptoms (Hospital Anxiety and Depression Scale, HADS)","Anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire comprising two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale ranges from 0 to 21. Higher scores indicate greater symptom severity (0-7: normal; 8-10: borderline abnormal; 11-21: abnormal).",{"measure":25,"description":26,"timeFrame":17},"Driving accident risk related to sleepiness (Bordeaux Sleepiness Scale, BOSS)","Driving accident risk related to sleepiness assessed using the Bordeaux Sleepiness Scale (BOSS). The total score ranges from 0 to 8, with higher scores indicating a greater risk of sleepiness-related driving impairment and accident risk",{"measure":28,"description":29,"timeFrame":17},"Hypersomnolence severity (Hypersomnia Severity Index, HSI)","Severity of hypersomnolence assessed using the Hypersomnia Severity Index (HSI), a patient-reported questionnaire with a total score ranging from 0 to 36. A total score of 10 or greater (or ≥ 11 in original validations) suggests clinically significant hypersomnolence, distinguishing individuals with sleep disorders from good sleepers",{"measure":31,"description":32,"timeFrame":17},"Fatigue severity (Fatigue Severity Scale, FSS)","Fatigue severity assessed using the Fatigue Severity Scale (FSS), a 9-item questionnaire scored from 1 to 7 for each item. The total score is calculated as the mean of the nine items and ranges from 1 to 7. Higher scores indicate greater fatigue severity.",{"measure":34,"description":35,"timeFrame":17},"Sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10, FOSQ-10)","Sleep-related quality of life assessed using the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), a 10-item questionnaire with a total score ranging from 5 to 20. Higher scores indicate better functional status and better quality of life related to sleep.",{"measure":37,"description":38,"timeFrame":17},"Physical and social functioning (12-Item Short Form Health Survey, SF-12)","Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12). The questionnaire provides two standardized component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), each ranging from 0 to 100. Higher scores indicate better physical and mental health status.",{"measure":40,"description":41,"timeFrame":17},"Sleep health (RU-SATED Sleep Health Scale)","Sleep health assessed using the RU-SATED Sleep Health Scale, which evaluates six dimensions of sleep health (Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration). The total score ranges from 0 to 24. Higher scores indicate better overall sleep health.",{"measure":43,"description":44,"timeFrame":17},"Nocturnal sleep complaints related to obstructive sleep apnea (Basic Nordic Sleep Questionnaire, BNSQ)","Nocturnal sleep complaints assessed using selected items from the Basic Nordic Sleep Questionnaire (BNSQ), including symptoms related to obstructive sleep apnea such as snoring, witnessed apneas, nocturnal awakenings, and non-restorative sleep. Higher scores indicate greater frequency or severity of nocturnal sleep complaints.",{"measure":46,"description":47,"timeFrame":17},"Global health status (Minimal European Health Module, MEHM)","Global health status assessed using the Minimal European Health Module (MEHM), a 3-item questionnaire evaluating self-perceived health, chronic morbidity, and activity limitation. Scores reflect overall health status, with higher scores indicating poorer perceived health and greater health limitations.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":48,"timePerspective":48,"maskingInfo":54},"NA","SINGLE_GROUP","Prospective, single-center, exploratory study.","BASIC_SCIENCE",{"masking":55,"maskingDescription":48,"whoMasked":48},"NONE",[57],{"label":58,"type":59,"description":60,"interventionNames":61},"Experimental group","EXPERIMENTAL","Patients who require a ventilatory polygraphy (VP) test as part of an initial evaluation for a high suspicion of OSA",[62],"Other: Questionnaires",[64],{"type":6,"name":65,"description":66,"armGroupLabels":67,"otherNames":48},"Questionnaires","Administration of the standard-of-care questionnaires: Bordeaux Sleepiness Scale (BOSS), Epworth Sleepiness Scale (ESS), Hypersomnia Severity Index (HSI), Insomnia Severity Index (ISI), Fatigue Severity Scale (FSS), Functional Outcomes of Sleep Questionnaire - 10 items (FOSQ-10), Hospital Anxiety and Depression Scale (HADS), 12-Item Short Form Health Survey (SF-12), Basic Nordic Sleep Questionnaire (BNSQ), and RU-SATED Sleep Health Scale (RU-SATED); and administration of the research questionnaires: Patient-Reported Apnea Questionnaire (PRAQ) and Minimal European Health Module (MEHM).",[58],[69,75],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},"Jean-Arthur MICOULAUD-FRANCHI, Pr","CONTACT","05 57 82 01 72","+33","jean-arthur.micoulaud-franchi@chu-bordeaux.fr",{"name":76,"role":71,"phone":48,"phoneExt":48,"email":77},"Julien COELHO, MD","julien.coelho@chu-bordeaux.fr",[79],{"facility":80,"status":48,"city":81,"state":48,"zip":48,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"CHU de Bordeaux","Bordeaux","France","FR",{"type":85,"coordinates":86},"Point",[87,88],-0.58046,44.84124,{"lat":88,"lon":87},[91,92,93],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},{"name":76,"role":71,"phone":48,"phoneExt":48,"email":48},{"name":94,"role":95,"phone":48,"phoneExt":48,"email":48},"Jean-Arthur Micoulaud-Franchi, Pr","PRINCIPAL_INVESTIGATOR",{"type":97,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100657268","patient-perceived-symptoms-at-the-center-of-obstructive-sleep-apnea-osa-management-validation-of-the-french-version-of-the-patient-reported-apnea-questionnaire-praq-100657268",false,"NCT07836062","Patient-Perceived Symptoms at the Center of Obstructive Sleep Apnea (OSA) Management: Validation of the French Version of the Patient-Reported Apnea Questionnaire (PRAQ)","PRAQ","Inclusion Criteria:\n\n* Age \\> 18 years\n* Patients referred through a direct referral pathway (outpatient or admitted to the SUMS) with a high suspicion of OSA\n* Patients whose native language is French and who can read and write French.\n* Patients capable of understanding and completing the questionnaires independently\n* Patients able to make themselves available for the tests offered as part of their care and for follow-up visits\n* Patients enrolled in or covered by a social security program\n* Patients who have been informed and do not object to participating in the study\n\nExclusion Criteria:\n\n* Current psychiatric disorder (mood disorders, anxiety, psychosis, substance use disorder interfering with sleep) assessed during the interview with the investigator\n* Current neurological disorder affecting sleep (neurodegenerative disease, stroke, epilepsy) assessed during the interview with the investigator\n* Unstable cardiovascular or respiratory diseases\n* Pregnant or breastfeeding women\n* Patients under legal guardianship\n* Refusal to participate expressed by the patient","ALL","18 Years",{"count":108,"type":109},100,"ESTIMATED","INTERVENTIONAL",[50],"Obstructive sleep apnea (OSA) is a common and disabling sleep disorder in which the assessment and monitoring of symptoms are central to patient management. However, these steps require a shared understanding of the disease's clinical manifestations among patients, caregivers, and healthcare professionals in order to establish common therapeutic goals and meaningful clinical outcomes.\n\nImproving symptoms as experienced and reported by patients has become a major public health priority at both the national and international levels. In France, this patient-centered approach has been identified as a strategic priority by the French National Authority for Health (Haute Autorité de Santé, HAS) in its 2019-2024 strategic plan. Its implementation has been supported through the development and use of Patient-Reported Outcome Measures (PROMs).\n\nA disease-specific PROM for OSA, the Patient-Reported Apnea Questionnaire (PRAQ), has recently been developed and validated. The primary objective of this study is to validate a French version of the PRAQ. Secondary objectives are to evaluate the relationship between PRAQ scores and subjective sleep parameters, and to develop a shortened version of the questionnaire to facilitate its use in both clinical practice and research.",[114],"Obstructive Sleep Apnea (OSA)",[116,103,117],"Obstructive sleep apnea","Patient-Reported Apnea Questionnaire","NOT_YET_RECRUITING","2026-09-17",{"date":121,"type":122},"2026-09-23","ACTUAL",{"date":124,"type":109},"2026-11-01",{"date":126,"type":109},"2029-04-30",{"name":5,"class":6},1]