The Effect of Mandibular Advancement Devices on Markers of Cardiovascular Health in Obstructive Sleep Apnea Patients
Key facts
- Who runs it
- University of Alberta
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 4 people enrolled
- Started
- 11 Jul 2021
- Ended
- 9 Sept 2024
- Type of study
- Observational
- Treatments tested
- mandibular advancement device (MAD)
- Record updated
- 19 September 2024
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Between ages of 18-70
- Diagnosed with Obstructive Sleep Apnea and prescribed with Mandibular Advancement Device
- No medical history of cardiovascular, pulmonary, renal diseases
Who cannot take part
- Any known cardiovascular, respiratory or pulmonary disease
- Have a history of smoking regularly in past 6 months
- Pre-existing symptomatic non-respiratory sleep disorder (restless leg syndrome, chronic insomnia)
- if more than 50% of their observed apneas are due to sleep apnea
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
Treatments tested
- mandibular advancement device (MAD)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 19 September 2024