Obstructive Sleep Apnea (OSA)PRAQNCT07836062
Patient-Perceived Symptoms at the Center of Obstructive Sleep Apnea (OSA) Management: Validation of the French Version of the Patient-Reported Apnea Questionnaire (PRAQ)
A study testing Questionnaires in people with Obstructive Sleep Apnea (OSA), run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean-Arthur MICOULAUD-FRANCHI, Pr contact
Julien COELHO, MD contact
France1 site
CHU de Bordeaux
Bordeaux
Jean-Arthur MICOULAUD-FRANCHI, Pr, 05 57 82 01 72 ext. +33, jean-arthur.micoulaud-franchi@chu-bordeaux.fr
Julien COELHO, MD
About this study
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)
- Being tested
- Questionnaires
- Keywords
- Obstructive sleep apnea, PRAQ, Patient-Reported Apnea Questionnaire
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients who require a ventilatory polygraphy (VP) test as part of an initial evaluation for a high suspicion of OSA Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Between 6 and 18months after inclusion (day 0)
Secondary outcomes (11)
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).
Measured: At inclusion (day 0)
Daytime sleepiness (Epworth Sleepiness Scale, ESS)
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.
Measured: At inclusion (day 0)
Anxiety and depressive symptoms (Hospital Anxiety and Depression Scale, HADS)
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).
Measured: At inclusion (day 0)
Driving accident risk related to sleepiness (Bordeaux Sleepiness Scale, BOSS)
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
Measured: At inclusion (day 0)
Hypersomnolence severity (Hypersomnia Severity Index, HSI)
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
Measured: At inclusion (day 0)
Fatigue severity (Fatigue Severity Scale, FSS)
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.
Measured: At inclusion (day 0)
Sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10, FOSQ-10)
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.
Measured: At inclusion (day 0)
Physical and social functioning (12-Item Short Form Health Survey, SF-12)
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.
Measured: At inclusion (day 0)
Sleep health (RU-SATED Sleep Health Scale)
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.
Measured: At inclusion (day 0)
Nocturnal sleep complaints related to obstructive sleep apnea (Basic Nordic Sleep Questionnaire, BNSQ)
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.
Measured: At inclusion (day 0)
Global health status (Minimal European Health Module, MEHM)
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.
Measured: At inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, exploratory study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836062
- Sponsor's protocol ID
- CHUBX 2025/032
- Acronym
- PRAQ
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Perceived Symptoms at the Center of Obstructive Sleep Apnea (OSA) Management: Validation of the French Version of the Patient-Reported Apnea Questionnaire (PRAQ)
- ClinicalTrials.gov ID
- NCT07836062
- Acronym / sponsor ID
- PRAQ / CHUBX 2025/032
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Obstructive sleep apnea, PRAQ, Patient-Reported Apnea Questionnaire
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, exploratory study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: QuestionnairesPatients who require a ventilatory polygraphy (VP) test as part of an initial evaluation for a high suspicion of OSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAdministration 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). | Other | Experimental group |
Primary outcome
Internal validity of PRAQ
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)
11 secondary outcomes
Insomnia severity (Insomnia Severity Index, ISI)
Time frame: At inclusion (day 0)
Daytime sleepiness (Epworth Sleepiness Scale, ESS)
Time frame: At inclusion (day 0)
Anxiety and depressive symptoms (Hospital Anxiety and Depression Scale, HADS)
Time frame: At inclusion (day 0)
Driving accident risk related to sleepiness (Bordeaux Sleepiness Scale, BOSS)
Time frame: At inclusion (day 0)
Hypersomnolence severity (Hypersomnia Severity Index, HSI)
Time frame: At inclusion (day 0)
Fatigue severity (Fatigue Severity Scale, FSS)
Time frame: At inclusion (day 0)
Sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10, FOSQ-10)
Time frame: At inclusion (day 0)
Physical and social functioning (12-Item Short Form Health Survey, SF-12)
Time frame: At inclusion (day 0)
Sleep health (RU-SATED Sleep Health Scale)
Time frame: At inclusion (day 0)
Nocturnal sleep complaints related to obstructive sleep apnea (Basic Nordic Sleep Questionnaire, BNSQ)
Time frame: At inclusion (day 0)
Global health status (Minimal European Health Module, MEHM)
Time frame: At inclusion (day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Arthur MICOULAUD-FRANCHI, Pr contact
Julien COELHO, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Obstructive Sleep Apnea (OSA), run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Arthur MICOULAUD-FRANCHI, Pr (05 57 82 01 72 ext. +33, jean-arthur.micoulaud-franchi@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal validity of PRAQ (time frame: Between 6 and 18months after inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.