Obstructive Sleep Apnoea Nervous System Diseases Sleep apnoea:obstructive
Conditions
Interventions
Visit 1 (Baseline)
1. Inclusion/Exclusion
2. Demographic Data (age, gender, height, weight, BMI, waist and neck circumference)
3. Polysomnography (PSG)
Sponsors
Philips Home Healthcare Solutions (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female, aged 21 years of age and above 2. Obstructive Sleep Apnoea with an Apnea Hypopnea Index (AHI) of greater than or equal to 30 confirmed by polysomnography 3. Epworth sleepiness scale (ESS) of greater than or equal to 11 4. Able to provide consent 5. Able to follow the instructions given by the investigator regarding using their APAP device and their participation in this study 6. Covered by National Health Insurance
Exclusion criteria
Exclusion criteria: 1. Positive airway pressure (PAP) therapy is otherwise medically contraindicated: acute upper respiratory infection, encephalitis, sinusitis or middle ear infection or surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days. 2. Untreated, non-OSA sleep disorders, including but not limited to; insomnia, Periodic Leg Movements (PLM) / Restless Legs Syndrome (RLS), Obesity Hypoventilation Syndrome (OHS), overlap syndrome and Central Sleep Apnoea (CSA) / Cheyne Stokes Respiration (CSR) associated with Heart Failure. 3. Treated Insomnia 4. Intake of central relevant drugs, sedatives, or other drugs which impair sleep 5. Previous exposure to positive airways pressure therapy 6. Acute dermatitis or other skin lesions or trauma interfering with the application of a mask 7. Unwilling to participate in the study 8. Participation in another clinical study in the past 4 weeks 9. Shift worker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The PR1 REMstar Auto with P-Flex reduces the Apnoea Hypopnoea Index (AHI) to less than 15 in patients with documented OSA, when measured using full polysomnography | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The PR1 REMstar Auto with P-Flex changes other indices of the polysomnography study in an acceptable manner (SpO2 ,total sleep time, Sleep efficiency and arousals) 2. The PR1 REMstar Auto with P-Flex reduces the Epworth Sleepiness Scale (ESS) to less than 11 in patients with documented OSA 3. Patients demonstrate a compliance of greater than or equal to 3 hours per 24 hrs when using the PR1 REMstar Auto with P-Flex 4. An average score of greater than or equal to 3 on the comfort and ease of use questionnaire 5. There will be an average pressure reduction of greater than or equal to 0.5 cm H2O using the P-Flex comfort mode | — |
Countries
France
Outcome results
None listed