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

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ClinicalTrials.gov Identifier: NCT01889472
Recruitment Status : Terminated (Inability to further include additional patients)
First Posted : June 28, 2013
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Frédéric Sériès, Laval University

Tracking Information
First Submitted Date  ICMJE June 19, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date January 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
diurnal somnolence [ Time Frame: After 4 weeks of CPAP trial ]
Epworth Sleepiness Score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2013)
Respiratory disturbances index [ Time Frame: After 4 weeks of CPAP trial ]
Provided by CPAP report
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment
Official Title  ICMJE Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy
Study Arms  ICMJE
  • Active Comparator: oro-nasal mask
    Oro-nasal mask during 1 month of auto CPAP
    Intervention: 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
    Intervention: Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 3, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
35
Actual Study Completion Date  ICMJE January 18, 2017
Actual Primary Completion Date January 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889472
Other Study ID Numbers  ICMJE MNB-003
JDBF-2012 ( Other Grant/Funding Number: JD Begin foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Frédéric Sériès, Laval University
Study Sponsor  ICMJE Laval University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederic Series, MD Fondation IUCPQ
PRS Account Laval University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP