RecruitingACTRN12619000475145

A comparison between positional therapy and continuous positive airway pressure therapy for positional obstructive sleep apnoea..

Prospective crossover trial of Positional and Continuous positive airway pressure Therapy for the treatment of mild-to-moderate positional obstructive sleep apnoea.


Sponsor

Dr Mal Wilson

Enrollment

30 participants

Start Date

Apr 4, 2019

Study Type

Interventional

Conditions

Summary

Obstructive sleep apnoea syndrome (OSAS) is a chronic disorder characterised by recurrent episodes of complete or partial upper airway obstruction during sleep contributing to repetitive arousals and subsequent symptoms of non-restorative sleep. In a subset of patients with OSA, obstructive events occur much more frequently during supine sleep. In such patients, considered to have positional OSA (pOSA), vibrotactile positional therapy has been shown to restrict supine sleep thereby reducing the severity of OSA, improving sleep architecture and depression scores. These devices can also be used to accurately monitor adherence and other treatment outcomes. This study will undertake a prospective crossover trial of positional and CPAP therapy in eligible patients (see Inclusion and Exclusion Criteria) with mild-to-moderate positional OSA. In a prospective, randomized crossover trial, patients with pOSA will undergo an 8 week trial of both positional therapy (NightShift) and CPAP. The primary end-point for comparison will be change in subjective sleepiness, as measured by the Epworth Sleepiness Scale (ESS).


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for positional obstructive sleep apnoea (pOSA) — a type of sleep apnoea where breathing problems mainly occur when sleeping on your back. The two treatments are CPAP (a mask that delivers continuous airflow to keep the airway open) and a vibrating wearable device worn at the back of the neck (called NightShift) that gently nudges you when you roll onto your back. Adults aged 18–65 with mild to moderate positional sleep apnoea confirmed by a sleep study, and who feel excessively sleepy during the day, will be randomly assigned to try each treatment for 8 weeks before switching to the other. The main measure is how sleepy participants feel (using the Epworth Sleepiness Scale), along with cognitive tests, sleep quality, and mood. You may be eligible if you are between 18 and 65, have been diagnosed with positional OSA on a sleep study, feel sleepy during the day, and have not previously used CPAP. People who are pregnant, work night shifts, drink heavily, have significant neurological or psychiatric conditions, or have severe sleep apnoea requiring urgent CPAP treatment cannot participate. This study aims to determine which approach works better for this specific group of sleep apnoea patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Positional Therapy (NightShift) In the positional therapy arm, patients will wear a NightShift during sleep at home for a period of 8 weeks. The NightShift device is a small position monitoring devic

Positional Therapy (NightShift) In the positional therapy arm, patients will wear a NightShift during sleep at home for a period of 8 weeks. The NightShift device is a small position monitoring device that is worn around the neck. The device vibrates when the wearer lays in the supine position and slowly increases in intensity until the wearer changes to a non-supine position. Adherence will be measured through the data downloaded from the NightShift device post-treatment (8 weeks). There is no washout period between treatments.


Locations(1)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12619000475145