Status:
TERMINATED
Implant Supported Oral Appliance Treatment of OSA
Lead Sponsor:
University of British Columbia
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment modality for the management of obstructive sleep apnea (OSA) in adults. The effectiveness of OAm therapy,...
Detailed Description
Mandibular advancement oral appliances (OAm) are devices that keep the airway open during sleep by pulling the lower jaw forward. OAm have been shown to be an effective treatment for both mild and sev...
Eligibility Criteria
Inclusion
- This trial will recruit 10 patients with an objective diagnosis of obstructive sleep apnea who are not naïve to treatment. The inclusion criteria are:
- Currently receive or have previously received successful OSA treatment with an OAm;
- Age 25 - 65 years old, who are able to freely provide informed consent;
- Body Mass Index (BMI) ≤ 35;
- Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years \*\*\*OR\*\*\*
- Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with Level III portable sleep test \*\*\*OR\*\*\*
- Oxygen Desaturation Index (ODI) ≥ 10
Exclusion
- The patient is excluded if it meets any of the following criteria:
- Extensive periodontal disease;
- Bleeding disorder;
- Bone metabolic disorder
- Immunocompromised
- Diabetes mellitus
- Xerostomia
- Titanium allergy
- Insufficient vertical opening to accommodate treatment with OAm;
- Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).
- Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
- Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
- Any history of angina, myocardial infarction or stroke;
- Any history of major depressive disorder along with current moderate-severe disease;
- Active cancer management (unless in remission for more than 1 year);
- Known renal failure (with need for dialysis)
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03362671
Start Date
April 1 2018
End Date
September 11 2019
Last Update
November 22 2022
Active Locations (1)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3