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

NCT03167684 | Unknown

• 1 other identifier: 2017-2769
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Blood pressure

  End of study (Week 20)

• Glucose variability

  End of study (Week 20)

• Changes in insulin or diabetes medication doses

  End of study (Week 20)

• Systemic inflammation

  End of study (Week 20)

Other Outcomes (2)

• Oral appliance therapy adherence

  Monitored from Week 0 to week 20 (8 week titration + 12 week treatment)

• Subjective sleep quality

  Screening or baseline (Week -4), Week 12 and End of study (Week 20)

Study Arms (2)

Oral appliance therapy

EXPERIMENTAL

Oral appliance (SomnoMed) worn nightly

Device: Oral appliance therapy

Control

NO INTERVENTION

Sham oral appliance device

Interventions

Oral appliance therapy DEVICE

Fitted oral appliance

Also known as: Mandibular advancement device

Oral appliance therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• University of British Columbia: collaborator

Study Sites (1)

McGill University Health Centre - Research Institute

Montreal, Quebec, H4A2Y3, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Sushmita Pamidi, MD MSc

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sushmita Pamidi, MD MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: May 30, 2017
• Study Start: May 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)