Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01889472
Other study ID # MNB-003
Secondary ID JDBF-2012
Status Terminated
Phase N/A
First received June 19, 2013
Last updated May 3, 2017
Start date June 2013
Est. completion date January 18, 2017

Study information

Verified date May 2017
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date January 18, 2017
Est. primary completion date January 18, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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


Locations

Country Name City State
Canada CHUM Montreal Quebec
Canada IUCPQ Quebec
France AGIRADOM Grenoble

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Countries where clinical trial is conducted

Canada,  France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Respiratory disturbances index Provided by CPAP report After 4 weeks of CPAP trial
Primary 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 diurnal somnolence Epworth Sleepiness Score After 4 weeks of CPAP trial
See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A