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

Type 2 Diabetes Mellitus Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03167684
• Other study ID #: 2017-2769
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Type 2 Diabetes Mellitus

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)