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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive; Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Oral appliance therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A2Y3
      • Recruiting
      • McGill University Health Centre - Research Institute
      • Contact: Sushmita Pamidi, MD
      • Principal Investigator: Sushmita Pamidi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral appliance therapy; Oral appliance (SomnoMed) worn nightly	Device: Oral appliance therapy; Fitted oral appliance; Other Names: Mandibular advancement device
No Intervention: Control; Sham oral appliance device

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral appliance therapy adherence	Measured by a chip embedded in the oral appliance	Monitored from Week 0 to week 20 (8 week titration + 12 week treatment)
Subjective sleep quality	Sleep questionnaires	Screening or baseline (Week -4), Week 12 and End of study (Week 20)

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: University of British Columbia
• Investigators: Principal Investigator: Sushmita Pamidi, MD MSc, Assistant Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 10, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Diabetes Mellitus; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2017-2769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Towards meta-analysis data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No