The POSA Trial
Research type
Research Study
Full title
Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to assess the effect on Health and Wellbeing in Older and Younger People.
IRAS ID
252494
Contact name
Julia Kelly
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Obstructive Sleep Apnoea (OSA) effects one in ten adults in the UK. It occurs when muscles in the upper airway relax during sleep, and the airway becomes partially or completely blocked. Breathing restarts when the person wakes up, but frequent night-time awakenings cause daytime sleepiness. It can also cause long-term heart problems, and in older people increase the risk of having a stroke.
The best treatment is Continuous Positive Airway Pressure (CPAP); it blows air into the lung to prevent the airway closing, which in turn improves sleep, and quality of life and reduces negative health risks. However, CPAP can be uncomfortable and difficult to use, especially for older people.
Sleeping on the back makes breathing worse for some patients with OSA, and can even be the cause of OSA in others, due to the effect of gravity on the upper airway. New technology has resulted in devices that use gentle vibrational feedback from position sensors to prevent people sleeping on their backs.
Therefore, this study aims to determine whether Positional Therapy, using a small vibrating device fitted to the neck, can help to stop people from sleeping on their backs, and whether this helps to reduce the severity of their OSA. We also want to determine whether patients feel better and how easy the treatment is to use. We also want to compare the effect in older and younger people.
Patients will be randomised to either Positional Therapy or Sham-Positional Therapy (placebo). We will measure breathing at night and compare the response to treatment in each group, and determine if this is different in older people. Questionnaires, before and after treatment, will determine the effect on patient’s sleep quality, daytime symptoms and quality of life. We will also assess the opinion of the bed-partner.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
19/YH/0222
Date of REC Opinion
4 Jul 2019
REC opinion
Favourable Opinion