Newly-diagnosed obstructive sleep apnea (OSA) patients treated by CPAP Respiratory Obstructive sleep apnea (OSA)
Conditions
Interventions
2 parallel arms randomized with a ratio 2:3
Group 1: ResMed Mirage FX nasal mask
Group 2: Fisher & Paykel Zest® or HC407®
or Philips Respironics EasyLife®
Patients treated with CPAP ResMed S9 AutoSet
Sponsors
ResMed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly-diagnosed Obstructive Sleep Apnoea / Hypopnoea Syndrome (OSAHS) patients 2. Daytime sleepiness and =3 of listed symptoms (snoring, morning headaches, reduced alertness, libido disorders, hypertension or nocturia) associated with an apnea-hypopnea index (AHI) of >30/h or 5-30/h with =10 respiratory event-related arousals with an increase in respiratory effort documented by polysomnography (PSG), 3. Central apnea index of =20%, 4. Absence of nocturnal mouth leaks detected during CPAP treatment initiation, 5. No known allergy to silicone, 6. Fitted with an automatic positive airway pressure (APAP) device (S9 AutoSet; ResMed)
Exclusion criteria
Exclusion criteria: 1. Refusal or unable to participate 2. First-line nasal mask other than those being assessed 3. Patient previously treated with CPAP/APAP or noninvasive positive pressure ventilation 4. Has undergone Ear, nose and throat (ENT) surgery within the previous 6 weeks 5. Significant epistaxis in the previous 6 months, 6. Patient participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mask acceptability, defined as continued use of the nasal mask assigned at randomization, at 3-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CPAP compliance at 3-month follow up measured automatically by the device 2. Home Care Provider interventions measured by number and duration of phone calls and home visits 3. Causes of both mask and CPAP failure | — |
Countries
France
Outcome results
None listed