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

L

Laval University

Status

Terminated

Conditions

Obstructive Sleep Apnea

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01889472
JDBF-2012 (Other Grant/Funding Number)
MNB-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups

oro-nasal mask
Active Comparator group
Description:
Oro-nasal mask during 1 month of auto CPAP
Treatment:
Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy
Nasal mask and oral appliance
Experimental group
Description:
Nasal mask and oral appliance during 1 month of auto CPAP
Treatment:
Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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