NCT04211350

SLEEP ON Your SIDE (SOS) Study

A Multi-center, Prospective, Randomized Crossover Study With the NightBalance SPT Compared to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of the NightBalance Sleep Position Trainer (SPT) to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA). Primary Objective: Efficacy and Adherence of the SPT over 3 months of use compared to PAP for the treatment of POSA. The study is run from centers in France, the UK and Germany.

Detailed description

Participants are randomly allocated to receive one of two treatments, either Automatic Positive Airway Pressure (APAP) or NightBalance Sleep Position Therapy for a three month period. Participants are sent home with instructions to use that device nightly at home for three months. After three months of using the first device, they return to the doctor for assessment of the efficacy of the device using a sleep test and the compliance read from the device. Upon conclusion of the first three month treatment period, patients receive the alternative treatment for a further three months. At the end of the second three month period, participants return to their doctor again to assess the efficacy of the last device and read the compliance. Before any treatment and after each treatment, patients undergo a sleep test and complete some questionnaires. During each treatment period, patients complete a healthcare utilization diary and report any problems.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	NightBalance Sleep Position Trainer (SPT)	NightBalance Sleep Position Trainer (SPT) avoids 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.
DEVICE	Automatic Positive Airway Pressure (APAP)	Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.

Timeline

• Start date: 2019-02-04
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2019-12-26
• Last updated: 2024-02-07

Locations

18 sites across 3 countries: France, Germany, United Kingdom