Patient-Perceived Symptoms at the Center of Obstructive Sleep Apnea (OSA) Management: Validation of the French Version of the Patient-Reported Apnea Questionnaire (PRAQ)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Internal validity of PRAQ
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental group
Patients who require a ventilatory polygraphy (VP) test as part of an initial evaluation for a high suspicion of OSA
干预措施: Questionnaires (Other)
结局指标
主要结局
Internal validity of PRAQ
时间窗: 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)
次要结局
- 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))
- Fatigue severity (Fatigue Severity Scale, FSS)(At inclusion (day 0))
- Sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10, FOSQ-10)(At inclusion (day 0))
- Physical and social functioning (12-Item Short Form Health Survey, SF-12)(At inclusion (day 0))
- Sleep health (RU-SATED Sleep Health Scale)(At inclusion (day 0))
- Nocturnal sleep complaints related to obstructive sleep apnea (Basic Nordic Sleep Questionnaire, BNSQ)(At inclusion (day 0))
- Global health status (Minimal European Health Module, MEHM)(At inclusion (day 0))