Comparing a Convenient Positional Therapy Device to CPAP for Treatment of Positional Obstructive Sleep Apnea, A Crossover Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Changi General Hospital
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Epworth Sleepiness Scale ( ESS)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Research staff assessing the outcomes of the study, the scoring of the sleep studies, and data analyses will be blinded.
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Night Shift positional device (Device)
Continuous positive airway pressure
Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period.
Intervention: continuous positive airway pressure (Device)
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)