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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)
Conditions: Obstructive Sleep Apnea (OSA)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: University Hospital, Bordeaux
Location: CHU de Bordeaux Bordeaux
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
* Patients able to make themselves available for the tests offered as part of their care and for follow-up visits
* Patients enrolled in or covered by a social security program
* Patients who have been informed and do not object to participating in the study
Exclusion Criteria:
* 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
* Patients under legal guardianship
* Refusal to participate expressed by the patient
Source: ClinicalTrials.gov (NCT07836062). StuddyBuddy aggregates publicly available trial information.