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

NCT ID: NCT03167684

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2020-03-31

Brief 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.

Detailed Description

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.

Conditions

Sleep Apnea, Obstructive; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral appliance therapy

Oral appliance (SomnoMed) worn nightly

Group Type: EXPERIMENTAL

Oral appliance therapy

Intervention Type: DEVICE

Fitted oral appliance

Control

Sham oral appliance device

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral appliance therapy

Fitted oral appliance

Intervention Type: DEVICE

Other Intervention Names

Mandibular advancement device

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Sushmita Pamidi

Clinician Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sushmita Pamidi, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine

Locations

McGill University Health Centre - Research Institute

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sushmita Pamidi, MD MSc

Role: CONTACT

sushmita.pamidi@mcgill.ca

514-934-1934 ext. 36479

Facility Contacts

Sushmita Pamidi, MD

Role: primary

Other Identifiers

2017-2769

Identifier Type: -

Identifier Source: org_study_id