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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

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

NCT ID

NCT03167684

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

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

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

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