search
Back to results

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

Primary Purpose

Sleep Apnea, Obstructive, Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oral appliance therapy
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill University Health Centre - Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral appliance therapy

Control

Arm Description

Oral appliance (SomnoMed) worn nightly

Sham oral appliance device

Outcomes

Primary Outcome Measures

Recruitment and retention rates
feasibility of study in T2DM
Glycemic control (mean 24-hour and nocturnal glucose)
24-hour continuous glucose monitoring

Secondary Outcome Measures

Blood pressure
Measurement of clinic blood pressure
Glucose variability
Continuous glucose monitoring system (ipro2, Medtronic)
Changes in insulin or diabetes medication doses
Reporting of dose change by participant or treating physician.
Systemic inflammation
hs-CRP

Full Information

First Posted
May 21, 2017
Last Updated
September 10, 2017
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT03167684
Brief Title
Effect of Oral Appliance Therapy on Glucose Levels in Patients With T2DM and OSA: A Pilot Trial
Official Title
The Effect of Oral Appliance Therapy on Cardiometabolic Outcomes in Patients With Type 2 Diabetes and Obstructive Sleep Apnea: A Pilot RCT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
University of British Columbia

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral appliance therapy
Arm Type
Experimental
Arm Description
Oral appliance (SomnoMed) worn nightly
Arm Title
Control
Arm Type
No Intervention
Arm Description
Sham oral appliance device
Intervention Type
Device
Intervention Name(s)
Oral appliance therapy
Other Intervention Name(s)
Mandibular advancement device
Intervention Description
Fitted oral appliance
Primary Outcome Measure Information:
Title
Recruitment and retention rates
Description
feasibility of study in T2DM
Time Frame
End of study (Week 20)
Title
Glycemic control (mean 24-hour and nocturnal glucose)
Description
24-hour continuous glucose monitoring
Time Frame
End of study (week 20)
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Measurement of clinic blood pressure
Time Frame
End of study (Week 20)
Title
Glucose variability
Description
Continuous glucose monitoring system (ipro2, Medtronic)
Time Frame
End of study (Week 20)
Title
Changes in insulin or diabetes medication doses
Description
Reporting of dose change by participant or treating physician.
Time Frame
End of study (Week 20)
Title
Systemic inflammation
Description
hs-CRP
Time Frame
End of study (Week 20)
Other Pre-specified Outcome Measures:
Title
Oral appliance therapy adherence
Description
Measured by a chip embedded in the oral appliance
Time Frame
Monitored from Week 0 to week 20 (8 week titration + 12 week treatment)
Title
Subjective sleep quality
Description
Sleep questionnaires
Time Frame
Screening or baseline (Week -4), Week 12 and End of study (Week 20)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sushmita Pamidi, MD MSc
Phone
514-934-1934
Ext
36479
Email
sushmita.pamidi@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sushmita Pamidi, MD MSc
Organizational Affiliation
Assistant Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre - Research Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A2Y3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sushmita Pamidi, MD
First Name & Middle Initial & Last Name & Degree
Sushmita Pamidi, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Towards meta-analysis data

Learn more about this trial

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

We'll reach out to this number within 24 hrs