Auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ): study protocol for a randomized controlled trial
1 Institute for Breathing and Sleep, Austin Hospital, Melbourne, Australia
2 Department of Respiratory and Sleep Medicine, Austin Hospital, Melbourne, Australia
3 University of Melbourne, Melbourne, Australia
4 Department of Medicine, University of British, Columbia, Canada
5 Victorian Spinal Cord Service Austin Hospital, Melbourne, Australia
6 University of Sydney, Sydney, Australia
7 Department of Respiratory Medicine and Centre for Sleep Health & Research, Royal North Shore Hospital, Sydney, Australia
8 Princess Alexandra Hospital, Queensland, Australia
9 Stoke Mandeville Hospital, Mandeville Road, Aylesbury, Buckinghamshire, England
10 Prince of Wales Spinal Medicine Department, Sydney, Australia
11 LaTrobe University, Melbourne, Australia
12 Department of Physiotherapy, Austin Hospital, Melbourne, Australia
13 University of Otago and Burwood Spinal Unit, Christchurch, New Zealand
14 Psychology Department, College of Arts, Victoria University, Melbourne, Victoria, Australia
15 The Bronowski Institute of Behavioural Neuroscience, Kyneton, Victoria, Australia
Trials 2013, 14:181 doi:10.1186/1745-6215-14-181Published: 19 June 2013
Quadriplegia is a severe, catastrophic injury that predominantly affects people early in life, resulting in lifelong physical disability. Obstructive sleep apnoea is a direct consequence of quadriplegia and is associated with neurocognitive deficits, sleepiness and reduced quality of life. The usual treatment for sleep apnoea is nasal continuous positive airway pressure (CPAP); however, this is poorly tolerated in quadriplegia. To encourage patients to use this therapy, we have to demonstrate that the benefits outweigh the inconvenience. We therefore propose a prospective, multinational randomized controlled trial of three months of CPAP for obstructive sleep apnoea after acute quadriplegia.
Specialist spinal cord injury centres across Australia, New Zealand, the UK and Canada will recruit medically stable individuals who have sustained a (new) traumatic quadriplegia (complete or incomplete second cervical to first thoracic level lesions). Participants will be screened for obstructive sleep apnoea using full, portable sleep studies. Those with an apnoea hypopnoea index greater than 10 per hour will proceed to an initial three-night trial of CPAP. Those who can tolerate CPAP for at least 4 hours on at least one night of the initial trial will be randomized to either usual care or a 3-month period of auto-titrating CPAP. The primary hypothesis is that nocturnal CPAP will improve neuropsychological functioning more than usual care alone. The secondary hypothesis is that the magnitude of improvement of neuropsychological function will be predicted by the severity of baseline sleepiness measures, sleep fragmentation and sleep apnoea. Neuropsychological tests and full polysomnography will be performed at baseline and 3 months with interim measures of sleepiness and symptoms of autonomic dysfunction measured weekly. Spirometry will be performed monthly. Neuropsychological tests will be administered by blinded assessors. Recruitment commenced in July 2009.
The results of this trial will demonstrate the effect of nocturnal CPAP treatment of obstructive sleep apnoea in acute quadriplegia. If CPAP can improve neurocognitive function after injury, it is likely that rehabilitation and subsequent community participation will be substantially improved for this group of predominantly young and severely physically disabled people.
Australian New Zealand Clinical Trial Registry ACTRN12605000799651