Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, Residual Sleepiness, Vigilance, Hypoxic Burden, Driving Simulation, Accident Risk
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.
Interventions
DIAGNOSTIC_TESTHypoxic burden computation, additional procedures and questionnaire
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This is an open-label interventional study with no masking of participants or investigators.
Intervention model description
Single-arm prospective interventional study evaluating vigilance, behavioral tests, polysomnographic markers and accident risk in treated obstructive sleep apnea patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Hypoxic Burden According to Post-Treatment Vigilance Status | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Baseline Hypoxic Burden and Mean Sleep Latency on the Maintenance of Wakefulness Test | 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. |
| Predictive Value of Baseline Polysomnographic and Psychobehavioral Markers for Maintenance of Wakefulness Test Results | 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. |
| 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 | 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. |
Countries
France
Outcome results
None listed