Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment

May 3, 2017 updated by: Frédéric Sériès, Laval University

Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea

CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • IUCPQ
    • Quebec
      • Montreal, Quebec, Canada
        • CHUM
  • France
      • Grenoble, France
        • AGIRADOM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • normal nasal breathing
  • dentition allowing for use of an oral appliance
  • absence of mandibular joint pathology
  • Patients requiring the use of a facial mask during CAPP titration due to presence of mouth leaks with a nasal/prong interface
  • Patients using CPAP less than 3 hours/day as prescribed following CPAP titration

Exclusion Criteria:

  • Clinical instability
  • smoking cessation
  • current weight loss strategy
  • Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy)
  • severe cardio-metabolic co-morbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: oro-nasal mask
Oro-nasal mask during 1 month of auto CPAP
Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy
EXPERIMENTAL: Nasal mask and oral appliance
Nasal mask and oral appliance during 1 month of auto CPAP
Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP compliance
Time Frame: After 4 weeks of CPAP trial
CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.
After 4 weeks of CPAP trial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diurnal somnolence
Time Frame: After 4 weeks of CPAP trial
Epworth Sleepiness Score
After 4 weeks of CPAP trial

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory disturbances index
Time Frame: After 4 weeks of CPAP trial
Provided by CPAP report
After 4 weeks of CPAP trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Frederic Series, MD, Fondation IUCPQ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

January 18, 2017

Study Completion (ACTUAL)

January 18, 2017

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (ESTIMATE)

June 28, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNB-003
  • JDBF-2012 (OTHER_GRANT: JD Begin foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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