title: Auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trial Registry ACTRN12605000799651.
authors.affiliation: Institute for Breathing and Sleep, Austin Hospital, Melbourne, Australia. david.berlowitz@austin.org.au
authors.forename: David J
authors.initials: DJ
authors.lastname: Berlowitz
authors.forename: Najib
authors.initials: N
authors.lastname: Ayas
authors.forename: Maree
authors.initials: M
authors.lastname: Barnes
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Brown
authors.forename: Peter A
authors.initials: PA
authors.lastname: Cistulli
authors.forename: Tim
authors.initials: T
authors.lastname: Geraghty
authors.forename: Alison
authors.initials: A
authors.lastname: Graham
authors.forename: Bonsan Bonne
authors.initials: BB
authors.lastname: Lee
authors.forename: Meg
authors.initials: M
authors.lastname: Morris
authors.forename: Fergal
authors.initials: F
authors.lastname: O'Donoghue
authors.forename: Peter D
authors.initials: PD
authors.lastname: Rochford
authors.forename: Jack
authors.initials: J
authors.lastname: Ross
authors.forename: Balraj
authors.initials: B
authors.lastname: Singhal
authors.forename: Jo
authors.initials: J
authors.lastname: Spong
authors.forename: Brooke
authors.initials: B
authors.lastname: Wadsworth
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Pierce
mesh_terms: D000208:Acute Disease; D001315:Australia; D001341:Autonomic Nervous System / Q000503:physiopathology; D002170:Canada; D002985:Clinical Protocols; D045422:Continuous Positive Airway Pressure; D006801:Humans; D009483:Neuropsychological Tests; D009520:New Zealand; D017286:Polysomnography; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011782:Quadriplegia / Q000150:complications* / Q000503:physiopathology / Q000523:psychology; D011788:Quality of Life; D012107:Research Design; D012890:Sleep; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D013147:Spirometry; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom