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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After a minimum of 28 days of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Lyon Croix Rousse | Lyon | 69004 | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Single-arm prospective interventional study evaluating vigilance, behavioral tests, polysomnographic markers and accident risk in treated obstructive sleep apnea patients.
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This is an open-label interventional study with no masking of participants or investigators.
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|
| 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. | 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. | From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |