Obstructive Sleep ApneaCRASH (French)NCT07545421
Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea
A study testing Hypoxic burden computation, additional procedures and questionnaire in people with Obstructive Sleep Apnea, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Obstructive sleep apnea (OSA) is a major cause of excessive daytime sleepiness and impaired vigilance, leading to an increased risk of road and occupational accidents. Despite effective treatment with continuous positive airway pressure (CPAP) or mandibular advancement devices, more than one third of treated patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Hypoxic burden computation, additional procedures and questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2026to 1 May 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
- Adults aged 18 years or older.
- Newly diagnosed moderate to severe obstructive sleep apnea, defined by an apnea-hypopnea index (AHI) ≥15 events/hour on diagnostic polysomnography.
- Indication for obstructive sleep apnea treatment (continuous positive airway pressure, mandibular advancement device, positional therapy, or wake-promoting pharmacological treatment) as determined by the treating clinician.
- Indication for Maintenance of Wakefulness Test due to reported sleepiness, declared or suspected accident risk, or professional driving or safety-related occupation.
Who cannot join
- Previous treatment for obstructive sleep apnea.
- Major cognitive impairment or language barrier preventing valid completion of vigilance tests or questionnaires.
- Refusal or inability to undergo the Maintenance of Wakefulness Test.
- Comorbid sleep disorders associated with hypersomnolence, including narcolepsy or idiopathic hypersomnia.
- Pregnant or breastfeeding women.
- Persons deprived of liberty by judicial or administrative decision, persons under legal protection (guardianship or curatorship), persons admitted to a health or social institution for reasons other than research, persons receiving compulsory psychiatric care, or persons not affiliated with a social security system or equivalent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital Lyon Croix Rousse
Lyon, 69004
Pierre Tankéré, MD PhD, +33 4 72 07 29 09, Pierre.tankere01@chu-lyon.fr
About this study
Official title: Determinants of Residual Daytime Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea: Impact of Baseline Hypoxic Burden and Evaluation of Alternatives to the Maintenance of Wakefulness Test
Obstructive sleep apnea (OSA) is a major cause of excessive daytime sleepiness and impaired vigilance, leading to an increased risk of road and occupational accidents. Despite effective treatment with continuous positive airway pressure (CPAP) or mandibular advancement devices, more than one third of treated patients report persistent subjective sleepiness and/or objective vigilance impairment.
The Maintenance of Wakefulness Test (MWT) is currently considered the legal reference test for the assessment of vigilance. However, its availability is limited and does not allow systematic and regular evaluation of all patients at risk.
This prospective study aims to identify determinants of residual daytime sleepiness and impaired vigilance in treated OSA, with a specific focus on the role of hypoxic burden at diagnosis. The study also aims to evaluate alternative behavioral and psychomotor tests as potential complementary tools to the MWT, and to assess their relationship with simulated driving performance and retrospective accident history.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Hypoxic burden computation, additional procedures and questionnaire
- Keywords
- Obstructive Sleep Apnea, Residual Sleepiness, Vigilance, Hypoxic Burden, Driving Simulation, Accident Risk
- 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.
Hypoxic burden computation, additional procedures and questionnaireDiagnostic test
Polysomnographic data from diagnostic and treatment nights are collected to compute hypoxic burden and other sleep-related parameters.
Procedures performed as part of usual clinical care include the Maintenance of Wakefulness Test and routine clinical questionnaires assessing sleep, sleepiness, insomnia, mood, chronotype and anxiety, including the Karolinska Sleepiness Scale.
Additional procedures performed for research purposes include the Osler test, the Psychomotor Vigilance Task, a simulated driving test, and research-specific questionnaires, including a mind wandering scale and a retrospective questionnaire assessing road and occupational accident history.
No experimental treatment is administered.
| Study group | Role | What they receive |
|---|---|---|
| Treated Obstructive Sleep Apnea Patients | Experimental | Adult patients diagnosed with moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hour), treated with continuous positive airway pressure or mandibular advancement device, and referred for Maintenance of Wakefulness Testing as part of clinical care Receives: Diagnostic Test: Hypoxic burden computation, additional procedures and questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Hypoxic Burden According to Post-Treatment Vigilance Status
Baseline hypoxic burden measured on diagnostic polysomnography, quantified as the cumulative depth and duration of oxygen desaturations associated with respiratory events. The primary analysis compares hypoxic burden between patients with impaired vigilance and those without impaired vigilance, defined by a mean sleep latency <33 minutes on the Maintenance of Wakefulness Test after treatment.
Measured: after a minimum of 28 days of treatment
Secondary outcomes (3)
Correlation Between Baseline Hypoxic Burden and Mean Sleep Latency on the Maintenance of Wakefulness Test
Association between baseline hypoxic burden measured on diagnostic polysomnography and mean sleep latency (in minutes) obtained from the four Maintenance of Wakefulness Test trials performed after treatment.
Measured: After a minimum of 28 days of treatment.
Predictive Value of Baseline Polysomnographic and Psychobehavioral Markers for Maintenance of Wakefulness Test Results
Correlation between mean sleep latency on the Maintenance of Wakefulness Test and baseline polysomnographic parameters (apnea-hypopnea index, time with SpO₂ <90%, microarousal index, sleep efficiency, sleep stage distribution) and psychobehavioral measures collected at diagnosis and during vigilance assessment.
Measured: After a minimum of 28 days of treatment.
Performance on Alternative Vigilance Tests Compared With the Maintenance of Wakefulness Test And Association Between Vigilance Tests and Simulated Driving Performance
Correlation between Maintenance of Wakefulness Test results and alternative behavioral vigilance tests, including the Osler test (sleep latency) and the Psychomotor Vigilance Task (reaction time, lapses, false alarms). Sensitivity, specificity, positive predictive value, and negative predictive value of alternative tests are calculated using a mean sleep latency <33 minutes on the Maintenance of Wakefulness Test as the reference and relationship between Maintenance of Wakefulness Test results and simulated driving performance, assessed by inappropriate lane crossings and standard deviation of lateral position during a standardized driving simulation.
Measured: From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 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 ApneaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective interventional study evaluating vigilance, behavioral tests, polysomnographic markers and accident risk in treated obstructive sleep apnea patients.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545421
- Sponsor's protocol ID
- 69HCL24_1173
- Acronym
- CRASH (French)
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 Apr 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Residual Daytime Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea: Impact of Baseline Hypoxic Burden and Evaluation of Alternatives to the Maintenance of Wakefulness Test
- ClinicalTrials.gov ID
- NCT07545421
- Acronym / sponsor ID
- CRASH (French) / 69HCL24_1173
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Residual Sleepiness, Vigilance, Hypoxic Burden, Driving Simulation, Accident Risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 22 Apr 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 major cause of excessive daytime sleepiness and impaired vigilance, leading to an increased risk of road and occupational accidents. Despite effective treatment with continuous positive airway pressure (CPAP) or mandibular advancement devices, more than one third of treated patients report persistent subjective sleepiness and/or objective vigilance impairment.
The Maintenance of Wakefulness Test (MWT) is currently considered the legal reference test for the assessment of vigilance. However, its availability is limited and does not allow systematic and regular evaluation of all patients at risk.
This prospective study aims to identify determinants of residual daytime sleepiness and impaired vigilance in treated OSA, with a specific focus on the role of hypoxic burden at diagnosis. The study also aims to evaluate alternative behavioral and psychomotor tests as potential complementary tools to the MWT, and to assess their relationship with simulated driving performance and retrospective accident history.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm prospective interventional study evaluating vigilance, behavioral tests, polysomnographic markers and accident risk in treated obstructive sleep apnea patients.
| Arm | Type | Receives |
|---|---|---|
| Treated Obstructive Sleep Apnea Patients | Experimental | Diagnostic Test: Hypoxic burden computation, additional procedures and questionnaireAdult patients diagnosed with moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hour), treated with continuous positive airway pressure or mandibular advancement device, and referred for Maintenance of Wakefulness Testing as part of clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Newly diagnosed moderate to severe obstructive sleep apnea, defined by an apnea-hypopnea index (AHI) ≥15 events/hour on diagnostic polysomnography.
- Indication for obstructive sleep apnea treatment (continuous positive airway pressure, mandibular advancement device, positional therapy, or wake-promoting pharmacological treatment) as determined by the treating clinician.
- Indication for Maintenance of Wakefulness Test due to reported sleepiness, declared or suspected accident risk, or professional driving or safety-related occupation.
Key exclusion criteria (6 listed)
- Previous treatment for obstructive sleep apnea.
- Major cognitive impairment or language barrier preventing valid completion of vigilance tests or questionnaires.
- Refusal or inability to undergo the Maintenance of Wakefulness Test.
- Comorbid sleep disorders associated with hypersomnolence, including narcolepsy or idiopathic hypersomnia.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Hypoxic burden computation, additional procedures and questionnairePolysomnographic data from diagnostic and treatment nights are collected to compute hypoxic burden and other sleep-related parameters. Procedures performed as part of usual clinical care include the Maintenance of Wakefulness Test and routine clinical questionnaires assessing sleep, sleepiness, insomnia, mood, chronotype and anxiety, including the Karolinska Sleepiness Scale. Additional procedures performed for research purposes include the Osler test, the Psychomotor Vigilance Task, a simulated driving test, and research-specific questionnaires, including a mind wandering scale and a retrospective questionnaire assessing road and occupational accident history. No experimental treatment is administered. | Diagnostic test | Treated Obstructive Sleep Apnea Patients |
Primary outcome
Baseline Hypoxic Burden According to Post-Treatment Vigilance Status
Time frame: after a minimum of 28 days of treatment
Baseline hypoxic burden measured on diagnostic polysomnography, quantified as the cumulative depth and duration of oxygen desaturations associated with respiratory events. The primary analysis compares hypoxic burden between patients with impaired vigilance and those without impaired vigilance, defined by a mean sleep latency <33 minutes on the Maintenance of Wakefulness Test after treatment.
3 secondary outcomes
Correlation Between Baseline Hypoxic Burden and Mean Sleep Latency on the Maintenance of Wakefulness Test
Time frame: After a minimum of 28 days of treatment.
Predictive Value of Baseline Polysomnographic and Psychobehavioral Markers for Maintenance of Wakefulness Test Results
Time frame: After a minimum of 28 days of treatment.
Performance on Alternative Vigilance Tests Compared With the Maintenance of Wakefulness Test And Association Between Vigilance Tests and Simulated Driving Performance
Time frame: From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test
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 22 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic burden computation, additional procedures and questionnaire in people with Obstructive Sleep Apnea, run by Hospices Civils de Lyon 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 4 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 22 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Hypoxic Burden According to Post-Treatment Vigilance Status (time frame: after a minimum of 28 days of treatment). 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 22 Apr 2026.