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

Phase 3

Completed

• Conditions: Acute tetraplegia; Obstructive Sleep Apnoea; Neurological - Other injuries and accidents; Musculoskeletal - Other injuries and accidents

• Registration Number: ACTRN12605000799651
• Lead Sponsor: Institute for Breathing and Sleep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurocognitive performance[After three months of therapy]

Secondary Outcome Measures

Name	Time	Method
Daytime, state sleepiness; Karolinska Sleepiness Scale score[Weekly for 3 months.];Respiratory function (spirometry)[Monthly (baseline, 1, 2 and 3 months)];Quality of Life. Measured with the Assessment of Quality of Life measure[Baseline and 3 months];Sleepiness and sleep symptoms. Basic Nordic Sleep Questionnaire[Baseline and 3 months];Anxiety and Depression. Hospital Depression and Anxiety Scale[Baseline and 3 months];Mood. Profile of Mood States[Baseline and 3 months]