Positional Therapy Versus CPAP for Positional OSA

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.

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

Conditions
-----------------
Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Device: Night Shift positional device
* Device: continuous positive airway pressure


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 8-week randomized crossover trial with a 1 week washout period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Night Shift positional device<br>Randomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period. | Device: Night Shift positional device<br>* 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.<br>|
| Active Comparator: Continuous positive airway pressure<br>Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period. | Device: continuous positive airway pressure<br>* Automated adjusting continuous positive airway pressure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale ( ESS) | Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use | 8 weeks after the beginning of each intervention | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea Syndromes, Positional sleep apnea, CPAP, Night Shift