The clinical effectiveness of a simple new treatment for supine-dependent obstructive sleep apnoea

Not Applicable

Active, not recruiting

• Conditions: Supine-predominant obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12613001242718
• Lead Sponsor: A/Prof Peter Catcheside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Age 18 to 75 years.
Epworth Sleepiness Scale score greater than or equal to 8.
No prior CPAP or BuzzPOD therapy.
Overnight diagnostic data indicating a diagnosis of supine-predominant obstructive sleep apnoea;
- Total AHI greater than 10 an hour
- Non-supine AHI less than 10 an hour
- Supine AHI greater than or equal to twice the non-supine AHI
- Total sleep greater than or equal to 4 hours
- Supine sleep time greater than or equal to 30 minutes
- Non-supine sleep time greater than or equal to 30 minutes

Exclusion Criteria

Potentially dangerous sleepiness requiring urgent treatment.
Epworth Sleepiness Scale score great than or equal to 16.
If participant is a commercial driver.
Co-morbidities that may preclude supine-avoidance treatment (e.g. arthritis, pacemaker).
Unwilling to cease current alternative OSA therapies for the duration of the trial.
Overnight diagnostic criteria indicating minimum blood oxygen saturation less than 80% for more than 10% of total sleep time.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in sleepiness (Epworth Sleepiness Scale)[Baseline, 3 weeks after the beginning of each treatment, 8 weeks after the beginning of each treatment.]

Secondary Outcome Measures

Name	Time	Method
Reduction in Apnea-Hypopnea Index[Baseline, 8 weeks after the beginning of each treatment.];Snoring (Snoring Scale Score)[Baseline, 8 weeks after the beginning of each treatment.];Resting blood pressure assessed using an automatic sphygmomanometer[Baseline, 8 weeks after the beginning of each treatment.];Sleep quality (Pittsburgh Sleep Quality Index, Functional Outcomes of Sleep Questionnaire)[Baseline, 8 weeks after the beginning of each treatment.];Quality of life (Assessment of Quality of Life - 8D)[Baseline, 8 weeks after the beginning of each treatment.];Treatment adherence - assessed by usage data downloaded from each device[Baseline, 3 weeks after the beginning of each treatment, 8 weeks after the beginning of each treatment.];Patient and partner satisfaction with treatment - assessed using an investigator designed questionnaire containing eight Visual Analogue Scale questions[Baseline, 8 weeks after the beginning of each treatment.]