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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03167684
Other study ID # 2017-2769
Secondary ID
Status Recruiting
Phase N/A
First received May 21, 2017
Last updated September 10, 2017
Start date May 1, 2017
Est. completion date March 2020

Study information

Verified date September 2017
Source McGill University Health Center
Contact Sushmita Pamidi, MD MSc
Phone 514-934-1934
Email sushmita.pamidi@mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 2020
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
Oral appliance therapy
Fitted oral appliance

Locations

Country Name City State
Canada McGill University Health Centre - Research Institute Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
McGill University Health Center University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other Subjective sleep quality Sleep questionnaires Screening or baseline (Week -4), Week 12 and End of study (Week 20)
Primary Recruitment and retention rates feasibility of study in T2DM End of study (Week 20)
Primary Glycemic control (mean 24-hour and nocturnal glucose) 24-hour continuous glucose monitoring End of study (week 20)
Secondary Blood pressure Measurement of clinic blood pressure End of study (Week 20)
Secondary Glucose variability Continuous glucose monitoring system (ipro2, Medtronic) End of study (Week 20)
Secondary Changes in insulin or diabetes medication doses Reporting of dose change by participant or treating physician. End of study (Week 20)
Secondary Systemic inflammation hs-CRP End of study (Week 20)
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