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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-01-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of OSA Syndrome

NCT04925739

Apnea, Obstructive

COMPLETED

Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of OSA With CPAP

NCT01909674

Obstructive Sleep Apnea (OSA)

COMPLETED NA

Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea

NCT02112435

Obstructive Sleep Apnea

COMPLETED NA

Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment

NCT01939938

Obstructive Sleep Apnea (OSA)

COMPLETED NA

Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea

NCT01461486

Mild Obstructive Sleep Apnea Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

oro-nasal mask

Oro-nasal mask during 1 month of auto CPAP

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Nasal mask and oral appliance

Nasal mask and oral appliance during 1 month of auto CPAP

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No