Sleep Apnea Syndromes
Conditions
Keywords
Sleep Apnea Syndromes, Positional sleep apnea, CPAP, Night Shift
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.
Interventions
DEVICENight Shift positional device
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.
DEVICEcontinuous positive airway pressure
Automated adjusting continuous positive airway pressure
Sponsors
Changi General Hospital
Study design
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.
Intervention model description
8-week randomized crossover trial with a 1 week washout period.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient adherence ( hours of device use per night) | 8 weeks after the beginning of each intervention | Compare patient adherence based on device download information |
| Patient preference | Upon study completion at week 17 | patient preference for treatment modality will be assessed via a questionnaire |
| Oxygen desaturation index (3%) and lowest oxygen saturation ( %) | 8 weeks after the beginning of each intervention | Oxygen indices |
| DASS21 questionnaire | 8 weeks after the beginning of each intervention | Difference in mood symptoms ( DASS21) |
| 36-Item Short Form Survey (SF-36) | 8 weeks after the beginning of each intervention | Difference in SF-36 |
| Pittsburgh Sleep Quality Index (PSQI) | 8 weeks after the beginning of each intervention | Difference in PSQI |
| Apnea-hypopnea Index ( AHI, events/hr) | 8 weeks after the beginning of each intervention | Difference in AHI |
| Functional Outcomes of Sleep Questionnaire ( FOSQ) | 8 weeks after the beginning of each intervention | Difference in FOSQ |
Countries
Singapore
Outcome results
None listed