CHU de Bordeaux
Bordeaux, France
Location contact
Jean-Arthur MICOULAUD-FRANCHI, Pr
CONTACT
05 57 82 01 72 ext. +33
Jean-Arthur Micoulaud-Franchi, Pr
PRINCIPAL_INVESTIGATOR
Julien COELHO, MD
CONTACT
NCT Number: NCT07836062
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Bordeaux, France
Jean-Arthur MICOULAUD-FRANCHI, Pr
CONTACT
05 57 82 01 72 ext. +33
Jean-Arthur Micoulaud-Franchi, Pr
PRINCIPAL_INVESTIGATOR
Julien COELHO, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Between 6 and 18months after inclusion (day 0)
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)
Time frame: At inclusion (day 0)
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).
Time frame: At inclusion (day 0)
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.
Time frame: At inclusion (day 0)
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).
Time frame: At inclusion (day 0)
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
Time frame: At inclusion (day 0)
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
Time frame: At inclusion (day 0)
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.
Time frame: At inclusion (day 0)
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.
Time frame: At inclusion (day 0)
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.
Time frame: At inclusion (day 0)
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.
Time frame: At inclusion (day 0)
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.
Time frame: At inclusion (day 0)
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Acronym: PRAQ
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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