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NCT05387122
The Effect of Mandibular Advancement Devices on Markers of Cardiovascular Health in Obstructive Sleep Apnea Patients
trial testing mandibular advancement device (MAD) in Obstructive Sleep Apnea in 4 participants. Completed in 9 September 2024.
9 September 2024
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 4 |
| Start date | 11 July 2021 |
| Primary completion | 9 September 2024 |
| Estimated completion | 9 September 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- mandibular advancement device (MAD)
Conditions studied
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Sponsor
University of Alberta
Who can join
Adults 18 to 70, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05387122
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Other University of Alberta trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05387122 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alberta
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05387122.
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