ovel brain biomarkers of performance impairment in sleep apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12613001171707
• 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: 2013-10-24
• Study Completion: 2014-11-26
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Age 25-65 years
Weight <150kg
PSG confirmed moderate to severe obstructive sleep apnea with an Apnea Hypopnea Index (AHI) of =15 events/hr and an Oxygen Desaturation Index (ODI) of =3% with =10 events/hr
Ability to read and speak English
Ability to perform neurobehavioural tests

Exclusion Criteria

Other PSG confirmed sleep disorders
OSA patients with clinically significant uncontrolled co-morbidity such as: cardiac failure, hypertension, hypercapnia, COPD, Type 1 diabetes
History of head injury or psychiatric/neurological disorders: clinical depression, epilepsy, mania or psychosis, stroke
Currently using CNS active medications/drugs such as: anti-depressives, anti-psychotics, opiates, antihistamines

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AusEd driving simulator lateral steering deviation[Driving simulator assessments occur 3 times during the Extended Wakefulness Protocol:<br><br>-Time 1 (baseline - 3.5 hours awake)<br>-Time 2 (20.5 hours awake)<br>-Time 3 (26.5 hours awake)]

Secondary Outcome Measures

Name	Time	Method
Psychomotor Vigilance Test (PVT) - a measure of simple reaction time and vigilance [assessed every 2 hours during the EWC]