CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
mandibular advancement device (MAD)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05387122
NCT05387122N/ACompleted

The Effect of Mandibular Advancement Devices on Markers of Cardiovascular Health in Mild to Moderate Obstructive Sleep Apnea Patients Who Are Non-Compliant With Continuous Positive Airway Pressure Therapy

University of Alberta·observational·Posted May 24, 2022·Updated Sep 19, 2024

In Brief

An observational study evaluating mandibular advancement device (MAD) for Obstructive Sleep Apnea. Completed, enrolled 4 participants across 1 site.

Detailed Summary

Obstructive sleep apnea (OSA) is a type of disordered breathing defined by the repetitive obstruction of airflow during sleep due to upper airway collapse. Each obstructive event contributes to decreased blood oxygen, or hypoxia. OSA has been associated with various cardiovascular diseases, including hypertension, stroke, heart failure, and coronary artery disease. A factor in this association may be the decrease in blood vessel health and the marked over activation of the sympathetic nervous system that is observed in OSA due to nighttime hypoxia. The sympathetic nervous system is responsible for maintaining heart and blood vessel (cardiovascular) balance. Elevated sympathetic nervous activity (SNA) is a likely cause of hypertension and subsequent cardiovascular disease. Continuous positive airway pressure (CPAP) therapy is the most accepted treatment for OSA and has been shown to improve high blood pressure and SNA in patients. An alternative therapy for OSA is a type of removable oral appliance known as a mandibular advancement device (MAD). Currently, there is no research directly measuring SNA in OSA patients using MADs. In addition to other cardiovascular markers, the investigators would like to directly assess SNA during a MAD intervention using the gold standard technique of microneurography. The investigators believe this will provide important information for the management of OSA, as levels of SNA are known to respond to both acute and chronic levels of hypoxia. Improved heart and blood vessel markers could further support MAD use, providing an important alternative therapy for those that can not tolerate CPAP.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 24, 2022
Enrollment StartJul 11, 2021
Primary CompletionSep 9, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 4.1 years ago

Interventions

mandibular advancement device (MAD)device

mandibular advancement device (MAD) is a removable oral appliance. It is an alternative therapy for patients of Obstructive Sleep Apnea who are non compliant to Continuous positive airway pressure(CPAP) which is the most accepted therapy for Obstructive Sleep Apnea.