Positional Therapy Versus CPAP for Positional OSA

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: continuous positive airway pressure; Device: Night Shift positional device

• Registration Number: NCT03125512
• Lead Sponsor: Changi General Hospital

Brief 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.

Study Timeline

• Study Start: 2017-02-27
• Study First Submitted: 2017-04-09
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Primary Completion: 2018-12-10
• Study Completion: 2018-12-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-05
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous positive airway pressure	continuous positive airway pressure	Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period.
Night Shift positional device	Night Shift positional device	Randomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period.

Primary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale ( ESS)	8 weeks after the beginning of each intervention	Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use

Secondary Outcome Measures

Name	Time	Method
Functional Outcomes of Sleep Questionnaire ( FOSQ)	8 weeks after the beginning of each intervention	Difference in FOSQ
Apnea-hypopnea Index ( AHI, events/hr)	8 weeks after the beginning of each intervention	Difference in AHI
36-Item Short Form Survey (SF-36)	8 weeks after the beginning of each intervention	Difference in SF-36
Patient preference	Upon study completion at week 17	patient preference for treatment modality will be assessed via a questionnaire
Patient adherence ( hours of device use per night)	8 weeks after the beginning of each intervention	Compare patient adherence based on device download information
Pittsburgh Sleep Quality Index (PSQI)	8 weeks after the beginning of each intervention	Difference in PSQI
DASS21 questionnaire	8 weeks after the beginning of each intervention	Difference in mood symptoms ( DASS21)
Oxygen desaturation index (3%) and lowest oxygen saturation ( %)	8 weeks after the beginning of each intervention	Oxygen indices

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore