Positional Therapy Versus CPAP for Positional OSA

Changi General Hospital41 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sleep Apnea Syndromes

Interventions

Night Shift positional deviceDEVICE

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.

continuous positive airway pressureDEVICE

Automated adjusting continuous positive airway pressure

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 21 years and above 2. Epworth sleepiness scale 10 to 16 3. No CPAP treatment or PT treatment for past 6 months 4. A diagnosis of positional OSA based on a full in-laboratory overnight polysomnography with 1. Total apnea/hypopnea index (AHI) \>10 /hour and non-supine AHI \< 10/hour 2. Supine AHI greater than or equal to two times the non-supine AHI 3. At least 15 minutes of supine and non-supine sleep Exclusion Criteria: 1. Epworth sleepiness scale ≥17 2. Commercial driving 3. Unable or unwilling to use both treatments (CPAP and PT) 4. Concurrent use of therapy for OSA such as mandibular advancement splints 5. Conditions that preclude the ability to lie in a non-supine position, for example a shoulder injury 6. Uncontrolled severe medical/psychiatric conditions such as severe chronic heart failure, malignancy. 7. Patients with pacemaker 8. Skin sensitivity around the neck and/or open wound around their neck

Locations (1)

Changi General Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Epworth Sleepiness Scale ( ESS)

Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use