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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea
Study Start Date : June 2013
Actual Primary Completion Date : January 18, 2017
Actual Study Completion Date : January 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. diurnal somnolence [ Time Frame: After 4 weeks of CPAP trial ]
    Epworth Sleepiness Score


Other Outcome Measures:
  1. Respiratory disturbances index [ Time Frame: After 4 weeks of CPAP trial ]
    Provided by CPAP report



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889472


Locations
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Canada, Quebec
CHUM
Montreal, Quebec, Canada
Canada
IUCPQ
Quebec, Canada, G1V 4G5
France
AGIRADOM
Grenoble, France
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Frederic Series, MD IUCPQ
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frédéric Sériès, Director IUCPQ sleep laboratory, Laval University
ClinicalTrials.gov Identifier: NCT01889472    
Other Study ID Numbers: MNB-003
JDBF-2012 ( Other Grant/Funding Number: JD Begin foundation )
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Keywords provided by Frédéric Sériès, Laval University:
CPAP compliance
leaks
Respiratory disturbances index
quality of life
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases