Sleep On your Side (SOS)
Research type
Research Study
Full title
A Multi-center, Prospective, Randomized Crossover Study with the NightBalance Lunoa SPT Compared to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)
IRAS ID
246757
Contact name
Timothy Quinnell
Contact email
ISRCTN Number
ISRCTN16170657
Duration of Study in the UK
1 years, 6 months, 29 days
Research summary
Obstructive Sleep Apnea (OSA) occurs in up to 10% of the general population and is characterised by repetitive pauses of breathing during sleep due to obstruction of the upper airway. Approximately 35% of patients with (OSA) have the majority of their events when sleeping on their back, called Positional OSA or POSA. Devices that discourage POSA patients sleeping on their back have shown promise. The Sleep Position Trainer (SPT) discourages POSA patients from sleeping on their back by delivering a vibrational stimulus, via a small device which is worn in a chest strap during sleep, each time the patient rolls to their back. This prompts the patient to roll over onto their side. Our research project will investigate the safety, efficacy and cost effectiveness of the SPT in patients with POSA by comparing it to the gold standard treatment for OSA, Continuous Positive Airway pressure (CPAP), in a crossover study in which patients use each treatment for 3 months. Safety will be assessed through an adverse event log. Efficacy will be assessed by measuring the number of times patients stop breathing during each treatment and compliance with each treatment. Symptomology and Quality of Life (QoL) will be assessed. A cost effectiveness analysis will be undertaken and Quality Adjusted Life Years (QALY) will be calculated.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0201
Date of REC Opinion
14 Aug 2018
REC opinion
Further Information Favourable Opinion