A prospective, randomised controlled trial of auto-titrating Continuous positive airway pressure treatment for Obstructive Sleep Apnoea after acute Quadriplegia

Conditions

None listed

Brief summary

The COSAQ trial aims to establish the impact on sleep function of using a CPAP nasal mask and pump at night. Continuous positive airway pressure (CPAP) is a nasal/facial mask and machine used at night to treat sleep apnoea. Although CPAP is the usual treatment for sleep apnoea, previous reports suggest that is poorly tolerated in acute quadriplegia. A maximum of 35% of those with chronic quadriplegia are adherent with therapy, with a higher rate of 50% in acute quadriplegia. A range of factors including severe immobility and psychological factors appear to contribute to a low acceptance of CPAP. The SHiQ COSAQ project will examine the impact on sleep function, quality of life and cognition of using CPAP, and establish whether the benefit of using CPAP is outweighed by the inconvenience of using it. People with quadriplegia have extremely high rates of sleep apnoea after injury which is undoubtedly limiting their rehabilitation. Successful treatment may improve acute, sub-acute and community outcomes for this group and demonstrate significant cost-utility.

David J. Berlowitz, Rachel Schembri, Marnie Graco, Jacqueline Ross, Najib Ayas et al. (24 authors)

Thorax2018-12-1123 citations

10.1136/thoraxjnl-2018-212319

A randomized controlled trial of auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ)

David J. Berlowitz

2016-09-01

10.1183/13993003.congress-2016.pa345

Auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ): study protocol for a randomized controlled trial.

Berlowitz DJ, Ayas N, Barnes M, Brown DJ, Cistulli PA, Geraghty T, Graham A, Lee BB, Morris M, O'Donoghue F, Rochford PD, Ross J, Singhal B, Spong J, Wadsworth B, Pierce RJ.

2013-06-1910 citations

10.1186/1745-6215-14-181

Papers published before 2003-12-01 may not appear yet. Historical indexing is in progress.

Interventions

Three months of nightly, nocturnal continuous positive airway pressure and usual care. The devices are auto-titrating, therefore the amount of pressure delivered is that which is sufficient to maintain a patent upper airway during sleep. Usual care is all other care provide to those with acute tetraplegia. This may include treatment for low lung volumes and retention of lung secretions.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Acute, traumatic quadriplegia. Obstructive Sleep Apnoea confirmed on full polysomnography. Able to tolerate at least four hours of CPAP use on at least one of first three nights on which the device is trialled.

Exclusion criteria

Successful CPAP therapy for OSA prior to injury Significant head injury (Glascow Coma Score < 8 at first assessment) Ongoing hypercapnic ventilatory failure (PaCO2 > 45 mmHg at randomisation) Likely inability to be followed up until 3 months Condition likely to significantly limit CPAP use (eg major psychoses, facial or base of skull fractures, etc)

Outcome results