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

Changi General Hospital1 site in 1 country41 target enrollmentFebruary 27, 2017

ConditionsSleep Apnea Syndromes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Apnea Syndromes
Sponsor: Changi General Hospital
Enrollment: 41
Locations: 1
Primary Endpoint: Epworth Sleepiness Scale ( ESS)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 27, 2017

End Date

December 30, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Changi General Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 21 years and above
•Epworth sleepiness scale 10 to 16
•No CPAP treatment or PT treatment for past 6 months
•A diagnosis of positional OSA based on a full in-laboratory overnight polysomnography with
•Total apnea/hypopnea index (AHI) \>10 /hour and non-supine AHI \< 10/hour
•Supine AHI greater than or equal to two times the non-supine AHI
•At least 15 minutes of supine and non-supine sleep

Exclusion Criteria

•Epworth sleepiness scale ≥17
•Commercial driving
•Unable or unwilling to use both treatments (CPAP and PT)
•Concurrent use of therapy for OSA such as mandibular advancement splints
•Conditions that preclude the ability to lie in a non-supine position, for example a shoulder injury
•Uncontrolled severe medical/psychiatric conditions such as severe chronic heart failure, malignancy.
•Patients with pacemaker
•Skin sensitivity around the neck and/or open wound around their neck

Outcomes

Primary Outcomes

Epworth Sleepiness Scale ( ESS)

Time Frame: 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 Outcomes

Functional Outcomes of Sleep Questionnaire ( FOSQ)(8 weeks after the beginning of each intervention)
Apnea-hypopnea Index ( AHI, events/hr)(8 weeks after the beginning of each intervention)
36-Item Short Form Survey (SF-36)(8 weeks after the beginning of each intervention)
Patient preference(Upon study completion at week 17)
Patient adherence ( hours of device use per night)(8 weeks after the beginning of each intervention)
Pittsburgh Sleep Quality Index (PSQI)(8 weeks after the beginning of each intervention)
DASS21 questionnaire(8 weeks after the beginning of each intervention)
Oxygen desaturation index (3%) and lowest oxygen saturation ( %)(8 weeks after the beginning of each intervention)