Recruiting

Oral Appliance Therapy

Sponsor:

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

Code:

NCT03167684

Conditions

Sleep Apnea, Obstructive

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral appliance therapy

Study Details

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.

Conditions

Sleep Apnea, Obstructive

Type 2 Diabetes Mellitus

Study ID

NCT03167684

Start date

May 1, 2017

Status verified date

Sep, 2017

Completion date

Mar, 2020

Anticipated

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral appliance therapy

Oral appliance (SomnoMed) worn nightly

no intervention: Control

Sham oral appliance device

Interventions

Oral appliance therapy

Fitted oral appliance

Primary outcome measure

  • Recruitment and retention rates [ Time Frame: End of study (Week 20) ]
  • Glycemic control (mean 24-hour and nocturnal glucose) [ Time Frame: End of study (week 20) ]

Central Contacts and Locations

Central contacts

Sushmita Pamidi, MD MSc

514-934-1934sushmita.pamidi@mcgill.ca

Locations

McGill University Health Centre - Research Institute

Recruiting

Montreal, Quebec, Canada, H4A2Y3

Principal Investigator:

Sushmita Pamidi, MD

More Information

Sponsor

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

Last update posted

Sep 12, 2017

Last verified

Sep, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2017-09-12.