Condition category
Respiratory
Date applied
17/04/2015
Date assigned
27/04/2015
Last edited
27/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Laurent Morin

ORCID ID

Contact details

ResMed
Parc Technologique de Lyon
292 Avenue Jacques Monod
Saint-Priest Cedex
69791
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial

Acronym

Study hypothesis

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

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

Study design

Muticentre randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

15/03/2011

Overall trial end date

30/12/2013

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Sample size: 228 patients (4 centers)

Participant 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

Recruitment start date

01/01/2012

Recruitment end date

31/07/2013

Locations

Countries of recruitment

France

Trial participating centre

Univ’Air Medical
St Germain-en-Laye
78100
France

Trial participating centre

Assistance Médicale Spécialisée (AMS)
Pau
64000
France

Trial participating centre

Santeol
Strasbourg
67000
France

Trial participating centre

MBAR Marc Baucher Assistance Respiratoire
Ballan-Miré
37510
France

Sponsor information

Organisation

ResMed

Sponsor details

Part Technologique de Lyon
292 Avenue Jacques Monod
Saint-Priest Cedex
69791
France

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

ResMed

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication of main results planned mid-2015 in peer-reviewed journal.

Intention to publish date

31/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes