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NCT Number: NCT07545421

Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Hypoxic burden computation, additional procedures and questionnaire

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. Predictive Value of Baseline Polysomnographic and Psychobehavioral Markers for Maintenance of Wakefulness Test Results

    Time frame: After a minimum of 28 days of treatment.

    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.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: CRASH (French)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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