Experimental Investigations of Driving Impairment in Obstructive Sleep Apnoea

Completed

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12610000009011
• Lead Sponsor: ational Health and Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Aged 25-70 years
At least 2 OSA symptoms (snoring, choking arousals or witnessed apneas, excessive daytime sleepiness)
Full Diagnostic polysomnogram showing an apnea/hypopnea index >15 events/hr, central apnea index <5/hr
untreated for OSA
Live in Adelaide (not country patients)
Full private standard driving license, drive at least 2 hours per week and have been driving in Australia for at least 2 years.

Exclusion Criteria

History of significant head injury
History of alcohol or drug abuse
History of central nervous system disease (e.g. past history of stroke)
Current use of medication which may affect driving (e.g. sedating antihistamines and opiates, regular use of hypnotics and other sedating psychotropic or anticonvulsant medication)
Sleep disorders such as narcolepsy, periodic limb movement disorder, restless legs syndrome, insomnia
Significant medical co-morbidities likely to affect sleep (e.g. severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in the first second (FEV1) <50%, significant cardiac failure (New York Heart Association [NYHA] 3 or 4), major depression).
Professional drivers
Night shiftworkers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Steering Deviation (deviations in median lane position of the virtual road measured in centimeters) will be assessed via computerised driving simulator and analysis software[Baseline and aproximately 3 months];Crashes (including off-road events, stopping events and truck collisions) will be assessed via computerised driving simulator and analysis software[Baseline and aproximately 3 months];Braking Reaction Time (measured as the speed of a braking in response to suddenly appearing trucks ahead of the virtual car) will be assessed via computerised driving simulator and analysis software[Baseline and aproximately 3 months]

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale assessed vian questionnaire[Baseline and 3 months]