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

N/A
Waitlist Available
Led By Sushmita Pamidi, MD MSc
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening or baseline (week -4), week 12 and end of study (week 20)
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Diabetes
  • Obstructive Sleep Apnea
  • Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening or baseline (week -4), week 12 and end of study (week 20)
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening or baseline (week -4), week 12 and end of study (week 20) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glycemic control (mean 24-hour and nocturnal glucose)
Recruitment and retention rates
Secondary study objectives
Blood pressure
Changes in insulin or diabetes medication doses
Glucose variability
+1 more
Other study objectives
Oral appliance therapy adherence
Subjective sleep quality

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oral appliance therapyExperimental Treatment1 Intervention
Oral appliance (SomnoMed) worn nightly
Group II: ControlActive Control1 Intervention
Sham oral appliance device

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
166,894 Total Patients Enrolled
University of British ColumbiaOTHER
1,476 Previous Clinical Trials
2,493,591 Total Patients Enrolled
Sushmita Pamidi, MD MScPrincipal InvestigatorAssistant Professor of Medicine
~6 spots leftby Dec 2025
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