NCT03125512

Positional Therapy Versus CPAP for Positional OSA

Comparing a Convenient Positional Therapy Device to CPAP for Treatment of Positional Obstructive Sleep Apnea, A Crossover Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a crossover randomized controlled trial comparing a convenient positional therapy (PT) device to continuous positive airway pressure (CPAP) in the treatment of positional obstructive sleep apnea (OSA).

Detailed description

This study aims to compare a convenient positional therapy (PT) device used for 8 weeks to continuous positive airway pressure (CPAP) used for 8 weeks in patients with positional obstructive sleep apnea (OSA) in a crossover randomized controlled trial.

Conditions

• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	Night Shift positional device	Night Shift is a small, positional therapy device that is worn at the back of the neck using a latex free silicone rubber strap. The strap is adjustable and is secured with a magnetic clasp. When a supine position is detected, the device vibrates with increasing intensity till the subject changes to a non-supine position.
DEVICE	continuous positive airway pressure	Automated adjusting continuous positive airway pressure

Timeline

• Start date: 2017-02-27
• Primary completion: 2018-12-10
• Completion: 2018-12-30
• First posted: 2017-04-24
• Last updated: 2019-05-07

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated device study