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

Study Overview
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Brief Summary
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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.

Detailed Description
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OSA is quite common in individuals with T2DM, occurring in as many as 60-80% of patients. The standard treatment for OSA is with the use of a CPAP machine. The CPAP provides an air pressure to keep the airways opened during sleep so that a person with OSA can breathe normally. When used appropriately, the CPAP improves sleepiness and quality of life. However, about half of the patients who receive a CPAP prescription cannot tolerate it and thus remain untreated and are potentially at increased cardiovascular and diabetes risk. In light of this, this study aims to see if the use of an alternative treatment for OSA, oral appliance therapy, where adherence is generally superior to CPAP, will improve cardiometabolic outcomes in individuals with Type 2 diabetes. This pilot trial will primarily examine feasibility and assess recruitment rates.

Official Title
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The Effect of Oral Appliance Therapy on Cardiometabolic Outcomes in Patients With Type 2 Diabetes and Obstructive Sleep Apnea: A Pilot RCT

Conditions
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Sleep Apnea, Obstructive, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: Oral appliance therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of T2DM using current Canadian guidelines OSA with AHI > 10 events/hour using current American Academy of Sleep Medicine (AASM) criteria for scoring respiratory events Exclusion Criteria: On treatment for OSA within the past 3 months Professional drivers or patients with an increased risk of driving-related accidents from clinical interview or severe subjective sleepiness (Epworth sleepiness scale greater than 15) Sleep apnea with any of the following features: highly severe OSA (AHI>50 and oxygen desaturation index > 50), severe hypoxemia (SpO2<80% for >10% of recording time), central sleep apnea or Cheyne-Stokes respirations with a central apnea index >10 events/hour Coexisting sleep disorder other than OSA Active cardiovascular disease, including angina, arrhythmia or congestive heart failure Insufficient dentition or significant periodontal disease or other contraindication for OAT as determined by dentist qualified in OSA treatment Active and significant psychiatric disease BMI>35 Regular use of sedatives or narcotics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral appliance therapy<br>Oral appliance (SomnoMed) worn nightly | Device: Oral appliance therapy<br>* Fitted oral appliance<br>* Other names: Mandibular advancement device;|
| No Intervention: Control<br>Sham oral appliance device | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment and retention rates | feasibility of study in T2DM | End of study (Week 20) | 
| Glycemic control (mean 24-hour and nocturnal glucose) | 24-hour continuous glucose monitoring | End of study (week 20) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Measurement of clinic blood pressure | End of study (Week 20) | 
| Glucose variability | Continuous glucose monitoring system (ipro2, Medtronic) | End of study (Week 20) | 
| Changes in insulin or diabetes medication doses | Reporting of dose change by participant or treating physician. | End of study (Week 20) | 
| Systemic inflammation | hs-CRP | End of study (Week 20) |