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Randomized Controlled Trial
. 2019 Mar;74(3):282-290.
doi: 10.1136/thoraxjnl-2018-212319. Epub 2018 Dec 11.

Positive airway pressure for sleep-disordered breathing in acute quadriplegia: a randomised controlled trial

David J Berlowitz  1   2 , Rachel Schembri  1 , Marnie Graco  1 , Jacqueline M Ross  1   3 , Najib Ayas  4 , Ian Gordon  5 , Bonne Lee  6 , Allison Graham  7 , Susan V Cross  7 , Martin McClelland  8 , Paul Kennedy  7 , Pradeep Thumbikat  8 , Cynthia Bennett  9 , Andrea Townson  10 , Timothy J Geraghty  11 , Sue Pieri-Davies  12 , Raj Singhal  13 , Karen Marshall  13 , Deborah Short  14 , Andrew Nunn  3 , Duncan Mortimer  15 , Doug Brown  16 , Robert J Pierce  1 , Peter A Cistulli  17   18 ; COSAQ Collaborative
Collaborators, Affiliations
Randomized Controlled Trial

Positive airway pressure for sleep-disordered breathing in acute quadriplegia: a randomised controlled trial

David J Berlowitz et al. Thorax. 2019 Mar.

Abstract

Rationale: Highly prevalent and severe sleep-disordered breathing caused by acute cervical spinal cord injury (quadriplegia) is associated with neurocognitive dysfunction and sleepiness and is likely to impair rehabilitation.

Objective: To determine whether 3 months of autotitrating CPAP would improve neurocognitive function, sleepiness, quality of life, anxiety and depression more than usual care in acute quadriplegia.

Methods and measurements: Multinational, randomised controlled trial (11 centres) from July 2009 to October 2015. The primary outcome was neurocognitive (attention and information processing as measure with the Paced Auditory Serial Addition Task). Daytime sleepiness (Karolinska Sleepiness Scale) was a priori identified as the most important secondary outcome.

Main results: 1810 incident cases were screened. 332 underwent full, portable polysomnography, 273 of whom had an apnoea hypopnoea index greater than 10. 160 tolerated at least 4 hours of CPAP during a 3-day run-in and were randomised. 149 participants (134 men, age 46±34 years, 81±57 days postinjury) completed the trial. CPAP use averaged 2.9±2.3 hours per night with 21% fully 'adherent' (at least 4 hours use on 5 days per week). Intention-to-treat analyses revealed no significant differences between groups in the Paced Auditory Serial Addition Task (mean improvement of 2.28, 95% CI -7.09 to 11.6; p=0.63). Controlling for premorbid intelligence, age and obstructive sleep apnoea severity (group effect -1.15, 95% CI -10 to 7.7) did not alter this finding. Sleepiness was significantly improved by CPAP on intention-to-treat analysis (mean difference -1.26, 95% CI -2.2 to -0.32; p=0.01).

Conclusion: CPAP did not improve Paced Auditory Serial Addition Task scores but significantly reduced sleepiness after acute quadriplegia.

Trial registration number: ACTRN12605000799651.

Keywords: sleep apnoea.

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Conflict of interest statement

Competing interests: DJB, NA and AT report a grant from the Rick Hansen Foundation during the conduct of the study. DM, PAC, BL, IG, DJB, DB and NA report a grant from the National Health and Medical Research Council during the conduct of the study. RJP, PK, DJB and DB report a grant from the Transport Accident Commission during the conduct of the study. All authors received non-financial support from ResMed during the conduct of the study. Outside the submitted work PAC has an appointment to an endowed academic chair at the University of Sydney that was created from ResMed funding. He has received research support from ResMed, SomnoMed and Zephyr Sleep Technologies. He is a consultant/adviser to Zephyr Sleep Technologies and ResMed (Narval). He has a pecuniary interest in SomnoMed related to a previous role in R&D (2004).

Figures

Figure 1
Figure 1
Participant flow through the study. AHI, apnoea hypopnoea index; OSA, obstructive sleep apnoea.
Figure 2
Figure 2
Individual participant and average change in the primary outcome measure (PASAT). Individual participants represented by dots. Solid dots represent those participants classified as adherent overall and thus included in the per protocol analyses. Three of six participants randomised to control and provided CPAP by their clinical care teams were adherent with CPAP. Horizontal lines represent the average change in the primary outcome measure. PASAT, Paced Auditory Serial Addition Task.
See this image and copyright information in PMC

Comment in

References

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