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

Primary Purpose

Obstructive Sleep Apnea

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring CPAP compliance, leaks, Respiratory disturbances index, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHUM
IUCPQ
AGIRADOM

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

oro-nasal mask

Nasal mask and oral appliance

Arm Description

Oro-nasal mask during 1 month of auto CPAP

Nasal mask and oral appliance during 1 month of auto CPAP

Outcomes

Primary Outcome Measures

CPAP compliance

CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.

Secondary Outcome Measures

diurnal somnolence

Epworth Sleepiness Score

Full Information

NCT ID

NCT01889472

First Posted

June 19, 2013

Last Updated

May 3, 2017

Sponsor

Laval University

1. Study Identification

Unique Protocol Identification Number

NCT01889472

Brief Title

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

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Inability to further include additional patients

Study Start Date

June 2013 (undefined)

Primary Completion Date

January 18, 2017 (Actual)

Study Completion Date

January 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

CPAP compliance, leaks, Respiratory disturbances index, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oro-nasal mask

Arm Type

Active Comparator

Arm Description

Oro-nasal mask during 1 month of auto CPAP

Arm Title

Nasal mask and oral appliance

Arm Type

Experimental

Arm Description

Nasal mask and oral appliance during 1 month of auto CPAP

Intervention Type

Device

Intervention Name(s)

Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy

Primary Outcome Measure Information:

Title

CPAP compliance

Description

CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.

Time Frame

After 4 weeks of CPAP trial

Secondary Outcome Measure Information:

Title

diurnal somnolence

Description

Epworth Sleepiness Score

Time Frame

After 4 weeks of CPAP trial

Other Pre-specified Outcome Measures:

Title

Respiratory disturbances index

Description

Provided by CPAP report

Time Frame

After 4 weeks of CPAP trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic Series, MD

Organizational Affiliation

Fondation IUCPQ

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHUM

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

IUCPQ

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

AGIRADOM

City

Grenoble

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

23691209

Citation

Borel JC, Tamisier R, Dias-Domingos S, Sapene M, Martin F, Stach B, Grillet Y, Muir JF, Levy P, Series F, Pepin JL; Scientific Council of The Sleep Registry of the French Federation of Pneumology (OSFP). Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One. 2013 May 15;8(5):e64382. doi: 10.1371/journal.pone.0064382. Print 2013.

Results Reference

background

PubMed Identifier

30689098

Citation

Leotard A, Lesgoirres M, Daabek N, Lebret M, Bailly S, Verain A, Series F, Pepin JL, Borel JC. Adherence to CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask: a randomized crossover trial. Sleep Breath. 2019 Sep;23(3):885-888. doi: 10.1007/s11325-018-01772-5. Epub 2019 Jan 28.

Results Reference

derived

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

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