Obstructive sleep apnoea Respiratory Sleep apnoea
Conditions
Interventions
This is a prospective, randomised, double-blinded parallel trial
Patients with positional OSA will be randomized to receive either Positional Therapy or Sham-Positional Therapy for 3 months. Study duration is expected to be 13 weeks for each participant
1 week for sleep study testing and baseline visit, plus 12 weeks of 'therapy'.
Screening: Patients will be screened using a home sleep study (Apnealink Air
ResMed, Australia). If the study shows the patient is eligible, an information sheet will be offered and written Informed Consent will be obtained. For sites with an alternative first-line sleep monit
including education on fitting and wearing, charging, and care. We have included a 10 minute run-in period where patients will self-fit the device, under instruction, and will experience the vibration
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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, = 4 hours of analysable signals 4. Ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA severity measured by the apnoea-hypopnoea index (AHI; number of breathing events per hour of sleep) at baseline and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective Sleep measures: 1.1 Overnight oxygenation (SaO2) measured by respiratory polygraphy (home sleep test) at baseline and 3 months 2. Quality of life and symptoms of OSA at baseline (pre-treatment) to 3 months (post-Positional Therapy): 2.1 Daytime sleepiness measured using the Epworth Sleepiness Scale (ESS) at baseline and 3 months 2.2 Anxiety and Depression measured by the Hospital, Anxiety and Depression Scale (HADS) at baseline and 3 months 2.3 Healthcare Utilisation measured by a Healthcare Contacts Questionnaire and by the Euroquol (EQ-5D) Questionnaire at baseline and 3 months 2.4 Quality of Life measured by the Short Form-36 (SF-36; specifically Energy and Vitality) at baseline and 3 months 2.5 Independent Functioning measured by the Townsend Disability Scale at baseline and 3 months 2.6 Sleep Quality and daytime functioning measured by the Functional Outcomes of Sleep Questionnaire and the Pittsburgh Sleep Quality Index (PSQI) at baseline and 3 months 3. Positional Therapy: 3.1 Comfort and tolerance of the Positional Therapy device measured using a Visual analogue scale (VAS) at 3 months 3.2 Adherence measured by the NightShift device (hours per night; number of nights used) over 3 months (90 days) 3.3 Sleeping position (including % time supine) measured by the Nightshift device at baseline and 3 months | — |
Countries
England, United Kingdom
Outcome results
None listed