Do ‘tired’ neurons that fall asleep in the awake brain underlie daytime impairments in obstructive sleep apnea?

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12619000549123
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-08
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

The participant's apnea-hypopnea index (AHI) must be greater than or equal to 15/hr to be eligible for the study. The symbol has been replaced with text below.

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Males and females;
Community-dwelling aged 35-65 years;
Polysomnography confirmed moderate to severe OSA based on the apnea-hypopnea index (AHI) greater than or equal to 15/hr;
Able to give informed consent;
Fluent in English;
Established CPAP users for a duration of at least 3 months (on average 4 hours use per night on at least 5 nights per week)
Ability to perform neurobehavioural tests and driving simulator task.
Current driver’s license
Vulnerable to driving impairment without CPAP therapy/upon withdrawal of therapy, Assessed via positive response(s) to questions reporting driving accidents or impairments prior to established CPAP therapy, and/or physician's opinion.

Exclusion Criteria

Clinically significant co-morbidity;
Major neurological problems (e.g. stroke, epilepsy, head injury);
Severe mental health disorder (e.g. current major depression, schizophrenia, bipolar disorder);
Regular use of sleep-affecting medication; benzodiazepines, opioids, antidepressants.
Shift worker or have traveled overseas within the last 2 weeks.
Professional drivers.
Sleep physician has advised against CPAP withdrawal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal sleep during wake measured as the change in task-related EEG-derived occipito-parietal theta power after repeated simulated driving (3 x 90 min drives at 11am, 2pm, 5pm), compared between CPAP on and CPAP off (withdrawal) conditions.[24-hour period encompassing night 2 (N-2) of the CPAP on condition, N-2 of the CPAP off condition. Resting wake EEG recording blocks at T3 block (7pm) - baseline block (10am) on Day 2.<br>];Mean steering deviation from the median lane position during the simulated drives, compared between the CPAP on and CPAP off (withdrawal) conditions.<br>[24-hour period encompassing night 2 (N-2) of the CPAP on condition, N-2 of the CPAP off condition. The three x 3-hourly, 90-minute sessions of driving on Day 2 after two nights of supervised CPAP/CPAP withdrawal. Drive 1 (Day 2, 11am), Drive 2 (Day 2, 2pm), Drive 3 (Day 2, 5pm).<br>]