NCT01889472

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

June 19, 2013

Last Update Submit

May 3, 2017

Conditions

Obstructive Sleep Apnea

Keywords

CPAP complianceleaksRespiratory disturbances indexquality of life

Outcome Measures

Primary Outcomes (1)

  • CPAP compliance

    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 Outcomes (1)

  • diurnal somnolence

    After 4 weeks of CPAP trial

Other Outcomes (1)

  • Respiratory disturbances index

    After 4 weeks of CPAP trial

Study Arms (2)

oro-nasal mask

ACTIVE COMPARATOR

Oro-nasal mask during 1 month of auto CPAP

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

Nasal mask and oral appliance

EXPERIMENTAL

Nasal mask and oral appliance during 1 month of auto CPAP

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

Interventions

Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapyDEVICE
Nasal mask and oral applianceoro-nasal mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHUM

Montreal, Quebec, Canada

Location

IUCPQ

Québec, G1V 4G5, Canada

Location

AGIRADOM

Grenoble, France

Location

Related Publications (2)

  • 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.

    PMID: 23691209BACKGROUND

  • 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.

    PMID: 30689098DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Frederic Series, MD

    Fondation IUCPQ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director IUCPQ sleep laboratory

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 28, 2013

Study Start

June 1, 2013

Primary Completion

January 18, 2017

Study Completion

January 18, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

CA(2)FR(1)