Patient-Perceived Symptoms at the Center of Obstructive Sleep Apnea (OSA) Management: Validation of the French Version of the Patient-Reported Apnea Questionnaire (PRAQ)

NCT07836062 | Not Yet Recruiting

• 1 other identifier: CHUBX 2025/032
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Obstructive sleep apnea; PRAQ; Patient-Reported Apnea Questionnaire

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (11)

• Insomnia severity (Insomnia Severity Index, ISI)

  At inclusion (day 0)

• Daytime sleepiness (Epworth Sleepiness Scale, ESS)

  At inclusion (day 0)

• Anxiety and depressive symptoms (Hospital Anxiety and Depression Scale, HADS)

  At inclusion (day 0)

• Driving accident risk related to sleepiness (Bordeaux Sleepiness Scale, BOSS)

  At inclusion (day 0)

• Hypersomnolence severity (Hypersomnia Severity Index, HSI)

  At inclusion (day 0)

Study Arms (1)

Experimental group

EXPERIMENTAL

Patients who require a ventilatory polygraphy (VP) test as part of an initial evaluation for a high suspicion of OSA

Other: Questionnaires

Interventions

Questionnaires OTHER

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).

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jean-Arthur MICOULAUD-FRANCHI, Pr

CONTACT

05 57 82 01 72; jean-arthur.micoulaud-franchi@chu-bordeaux.fr

Julien COELHO, MD

CONTACT

julien.coelho@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, exploratory study.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

FR (1)