The POSA Trial: Does positional therapy, delivered by a small vibrating neck device, improve the health and well-being of patients with positional obstructive sleep apnoea?
- Conditions
- Obstructive sleep apnoeaRespiratorySleep apnoea
- Registration Number
- ISRCTN51740863
- Lead Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1. Aged > = 18 years
2. Ability and willingness to provide informed consent
3. AHI > 5 events/hour (AASM 2012 scoring criteria) with events occurring at a frequency of 2:1 when supine, compared to non-supine; total % supine sleep > 20, < 90% of total sleep; central apnoeas < 20% total apnoeas; recording of > = 4 hours of analysable signals
4. Ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation
1. Unstable cardiac disease
2. Cardiac arrhythmia corrected with an artificial pacemaker
3. Supplemental oxygen
4. Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome; or shift workers
5. Concerns about sleepy driving or any other potentially dangerous symptom from physician
6. BMI > = 40 kg/m2
7. Inability to sleep in a non-supine position
8. Skin sensitivity or an open wound around neck
9. Neck circumference < 12inches (30cm) or > 22inches (55cm)
10. Tics or tremors of the head
11. Sleep with head in upright position
12. A female of child-bearing potential that is pregnant or intends to become pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OSA severity measured by the apnoea-hypopnoea index (AHI; number of breathing events per hour of sleep) at baseline and 3 months
- Secondary Outcome Measures
Name Time Method