Positional Therapy Versus CPAP for Positional OSA

Changi General Hospital

Status: Completed

Conditions: Sleep Apnea Syndromes

Treatments: Device: continuous positive airway pressure; Device: Night Shift positional device

Study type: Interventional

Funder types: Other

Identifiers

NCT03125512

OSA_RCT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Night Shift positional device

Experimental group

Description:

Randomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period.

Treatment:

Device: Night Shift positional device

Continuous positive airway pressure

Active Comparator group

Description:

Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period.

Treatment:

Device: continuous positive airway pressure