Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea

NCT07545421 | Not Yet Recruiting

• 1 other identifier: 69HCL24_1173
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Obstructive Sleep Apnea; Residual Sleepiness; Vigilance; Hypoxic Burden; Driving Simulation; Accident Risk

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  After a minimum of 28 days of treatment.

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

  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

  From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test

Study Arms (1)

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

Diagnostic Test: Hypoxic burden computation, additional procedures and questionnaire

Interventions

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.

Treated Obstructive Sleep Apnea Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Lyon Croix Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label interventional study with no masking of participants or investigators.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm prospective interventional study evaluating vigilance, behavioral tests, polysomnographic markers and accident risk in treated obstructive sleep apnea patients.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)