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

N/ANot Yet RecruitingNCT07836062

University Hospital, Bordeaux100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

100

Conditions

Obstructive Sleep Apnea (OSA)

QuestionnairesOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Bordeaux

Bordeaux, France

Outcomes

Primary Outcomes

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)

Time frame: Between 6 and 18months after inclusion (day 0)

Secondary Outcomes

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).