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Effect of Oral Appliance Therapy on Glucose Levels in Patients With T2DM and OSA: A Pilot Trial

NCT03167684 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-09-12

No results posted yet for this study

Summary

This study will evaluate the impact on blood glucose of the use of an oral appliance to treat obstructive sleep apnea (OSA) in individuals with Type 2 diabetes. An oral appliance is similar to a sports mouth guard or an orthodontic retainer and is an alternative treatment to continuous positive airway pressure (CPAP) for OSA. Oral appliance therapy has not been evaluated in patients with Type 2 diabetes with respect to glycemic outcomes. This will be a 1:1 randomized controlled trial: The experimental group will receive the oral appliance and the control group will receive a sham device over the course of approximately 5 months.

Conditions

Interventions

DEVICE

Oral appliance therapy

Fitted oral appliance

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Sushmita Pamidi, MD MSc · Assistant Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2019-03-31
Completion
2020-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03167684 on ClinicalTrials.gov