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

Inclusion Criteria6

  • Supine predominant positional obstructive sleep apnoea (pOSA) as defined by a total AHI >5 with a supine-to-non-supine AHI ratio >=2 on diagnostic PSG
  • Mild-to-moderate (>=5 AHI <30) severity pOSA
  • Symptomatic as defined by Epworth Sleepiness Score (ESS) >10
  • English-speaking adult patients
  • Able to perform neurocognitive tests
  • Able to provide informed consent.

Exclusion Criteria8

  • Evidence of significant hypoxia (>=5% total sleep time <90% SpO2) on PSG
  • Clinically significant co-morbidity (including history of head injury, stroke or neuro-/psychiatric disorder)
  • Use of centrally-acting medications
  • Heavy alcohol consumption (>40g/day)
  • Pregnancy
  • Current shift worker;
  • Previous use of CPAP
  • Very severe symptoms which in the opinion of the treating physician requires urgent treatment with CPAP

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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