Sleep apnea Respiratory Positional obstructive sleep apnea
Conditions
Interventions
Participants are randomised to receive either Automatic Positive Airway Pressure (APAP), the gold standard treatment for Obstructive Sleep Apnea (OSA), or Lunoa Sleep Position Therapy for a three mont
Sponsors
Philips
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is adult 2. Either: 2.1. Treatment naïve, or 2.2. PAP non-complier (defined as current AAP user with 15 during PSG with symptoms of sleepiness per Investigator discretion, or AHI of >15 during respiratory polygraphy with comorbidities (e.g. atrial fibrillation, resistant hypertension, etc.) 3.2. Supine AHI at least twice the lateral AHI 3.3. Lateral AHI 30% and <70% 4. Understands the study protocol and is willing and able to comply with study requirements and sign informed consent. APAP non-compliant subjects must be willing to use their APAP device per protocol.
Exclusion criteria
Exclusion criteria: 1. Prior or current therapy or treatment for OSA (for Treatment naïve group); Greater than an average of 3 hours per night of APAP use (in the APAP non-complier group) 2. A female of child-bearing potential that is pregnant or intends to become pregnant 3. Any unstable or severe medical condition of any organ system that at the discretion of the site Principal Investigator (PI) might affect the patient’s participation in the study or generalization of treatment results 4. Taking medication that at the discretion of the site Principal Investigator (PI) might affect the patient’s participation in the study or generalization of treatment results 5. Oxygen use 6. The presence of any other sleep disorder (central sleep apnea (CSA >5), periodic limb movement disorder (PLMAI >15), clinical diagnosis of insomnia or narcolepsy) 7. Excessive alcohol consumption (>21 drinks/week) 8. The use of any illegal drug(s), per subject report 9. Night or rotating shift work 10. Severe claustrophobia 11. Shoulder, neck, or back complaints that restrict sleeping position 12. Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Severity of sleep apnea is measured using apnea-hypopnea index (AHI) measured with polysomnography at baseline and at the end of each 3-month treatment arm 2. Adherence is measured by downloading the data from the devices at the end of each 3-month treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daytime sleepiness is measured using ESS at baseline and at the end of each 3 month treatment arm. 2. Impact of sleepiness on activities of daily living is measured using FOSQ at baseline and at the end of each 3 month treatment arm. 3. Health related quality of life is measured using EQ-5D at baseline and at the end of each 3 month treatment arm. 4. Fatigue is measured using Pichot Fatigue Scale at baseline and at the end of each 3 month treatment arm. 5. Quality of life is measured using SF-36 at baseline and at the end of each 3 month treatment arm. 6. Patient Comfort and Satisfaction is measured using Likert scales at baseline and at the end of each 3 month treatment arm. 7. Mean Disease Alleviation is calculated using the AHI and adherence data at the end of each 3-month treatment arm 8. Adverse events are recorded at the end of each 3-month treatment arm 9. Health Economics and Resource Utilization are assessed using healthcare utilization diary which is completed by patients during each 3-month treatment arm | — |
Countries
England, France, Germany, Scotland, United Kingdom, Wales
Contacts
Public ContactEllen Dutman
Outcome results
None listed