Clinical trial NCT03167684: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Type 2 Diabetes Mellitus
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2017-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment and retention rates
timeFrame: End of study (Week 20)
measure: Glycemic control (mean 24-hour and nocturnal glucose)
timeFrame: End of study (week 20)
Secondary outcomes:
measure: Blood pressure
timeFrame: End of study (Week 20)
measure: Glucose variability
timeFrame: End of study (Week 20)
measure: Changes in insulin or diabetes medication doses
timeFrame: End of study (Week 20)
measure: Systemic inflammation
timeFrame: End of study (Week 20)
Other outcomes:
measure: Oral appliance therapy adherence
timeFrame: Monitored from Week 0 to week 20 (8 week titration + 12 week treatment)
measure: Subjective sleep quality
timeFrame: Screening or baseline (Week -4), Week 12 and End of study (Week 20)
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre - Research Institute
state: Quebec
Study officials:
affiliation: Assistant Professor of Medicine
name: Sushmita Pamidi, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: