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.
Improving 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).
A 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.
Age > 18 years
Patients referred through a direct referral pathway (outpatient or admitted to the SUMS) with a high suspicion of OSA
Patients whose native language is French and who can read and write French.
Patients capable of understanding and completing the questionnaires independently
Current psychiatric disorder (mood disorders, anxiety, psychosis, substance use disorder interfering with sleep) assessed during the interview with the investigator
Current neurological disorder affecting sleep (neurodegenerative disease, stroke, epilepsy) assessed during the interview with the investigator
Unstable cardiovascular or respiratory diseases
Pregnant or breastfeeding women
Single group
Questionnaires
Other interventionAdministration 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).
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)
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).
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.
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).
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
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
