Comparison of adherence of different nasal masks in Obstructive Sleep Apnea patients treated by CPAP therapy
| ISRCTN | ISRCTN39453867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39453867 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/04/2015
- Registration date
- 27/04/2015
- Last edited
- 27/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Obstructive Sleep Apnoea (OSA) is a very common condition characterised by repetitive episodes of complete or partial upper airway obstruction during sleep. Continuous positive airway pressure therapy (CPAP) is the best available treatment for OSA: it helps people breathe more easily during sleep by delivering a constant level of pressure. However CPAP is not always well tolerated and 8–15% of patients stop treatment after one night. The mask is an essential element of CPAP and mask discomfort is often the reason for stopping CPAP. Also, the choice of initial mask is critical to avoid repeated interface changes that impact on patient motivation and increase costs. There have been few studies on the influence of the choice of mask on CPAP. The aim of this study is to compare different nasal masks in patients with OSA treated by CPAP.
Who can participate?
Newly-diagnosed sleepy OSA patients.
What does the study involve?
Participants are allocated to one of two groups:
Group 1 (MFX group) receives CPAP (AutoSet, ResMed) via ResMed Mirage FX® nasal mask.
Group 2 (Control group) receives CPAP (AutoSet, ResMed) via Fisher & Paykel Zest® or HC407®; or Philips Respironics EasyLife® nasal mask.
What are the possible benefits and risks of participating?
Possible benefits are better mask comfort and CPAP therapy adherence. No additional risk.
Where is the study run from?
4 centres in France
When is the study starting and how long is it expected to run for?
March 2011 to December 2013
Who is funding the study?
ResMed (France)
Who is the main contact?
Dr Laurent Morin
Contact information
Scientific
ResMed
Parc Technologique de Lyon
292 Avenue Jacques Monod
Saint-Priest Cedex
69791
France
Study information
| Study design | Muticentre randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial |
| Study objectives | Patient interface is important for the success of continuous positive airway pressure (CPAP) but few trials have examined the influence of mask choice on CPAP. This study compared the impact of different nasal masks on CPAP in patients with newly-diagnosed obstructive sleep apnea (OSA) who were randomized to receive CPAP via different first-line nasal masks. |
| Ethics approval(s) | French Ethicd Committee (Comité Consultatif sur le Traitement de l’Information en matière de Recherche dans le domaine de la Santé n: 11.414) and authorization of the French Data Processing Commission (Commission Nationale de L’Informatique et des Libertés n: 911341), 11/07/2011, ref number 11.414 |
| Health condition(s) or problem(s) studied | Newly-diagnosed obstructive sleep apnea (OSA) patients treated by CPAP |
| Intervention | 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 |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Mask acceptability, defined as continued use of the nasal mask assigned at randomization, at 3-month follow-up |
| Secondary outcome measures | 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 |
| Overall study start date | 15/03/2011 |
| Completion date | 30/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Sample size: 228 patients (4 centers) |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 31/07/2013 |
Locations
Countries of recruitment
- France
Study participating centres
78100
France
64000
France
67000
France
37510
France
Sponsor information
Industry
Part Technologique de Lyon
292 Avenue Jacques Monod
Saint-Priest Cedex
69791
France
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication of main results planned mid-2015 in peer-reviewed journal. |
| IPD sharing plan |
