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

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ClinicalTrials.gov Identifier: NCT03167684
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Sushmita Pamidi, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Type 2 Diabetes Mellitus Device: Oral appliance therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Oral Appliance Therapy on Cardiometabolic Outcomes in Patients With Type 2 Diabetes and Obstructive Sleep Apnea: A Pilot RCT
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Oral appliance therapy
Oral appliance (SomnoMed) worn nightly
Device: Oral appliance therapy
Fitted oral appliance
Other Name: Mandibular advancement device

No Intervention: Control
Sham oral appliance device



Primary Outcome Measures :
  1. Recruitment and retention rates [ Time Frame: End of study (Week 20) ]
    feasibility of study in T2DM

  2. Glycemic control (mean 24-hour and nocturnal glucose) [ Time Frame: End of study (week 20) ]
    24-hour continuous glucose monitoring


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: End of study (Week 20) ]
    Measurement of clinic blood pressure

  2. Glucose variability [ Time Frame: End of study (Week 20) ]
    Continuous glucose monitoring system (ipro2, Medtronic)

  3. Changes in insulin or diabetes medication doses [ Time Frame: End of study (Week 20) ]
    Reporting of dose change by participant or treating physician.

  4. Systemic inflammation [ Time Frame: End of study (Week 20) ]
    hs-CRP


Other Outcome Measures:
  1. Oral appliance therapy adherence [ Time Frame: Monitored from Week 0 to week 20 (8 week titration + 12 week treatment) ]
    Measured by a chip embedded in the oral appliance

  2. Subjective sleep quality [ Time Frame: Screening or baseline (Week -4), Week 12 and End of study (Week 20) ]
    Sleep questionnaires



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167684


Contacts
Contact: Sushmita Pamidi, MD MSc 514-934-1934 ext 36479 sushmita.pamidi@mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre - Research Institute Recruiting
Montreal, Quebec, Canada, H4A2Y3
Contact: Sushmita Pamidi, MD         
Principal Investigator: Sushmita Pamidi, MD         
Sponsors and Collaborators
McGill University Health Center
University of British Columbia
Investigators
Principal Investigator: Sushmita Pamidi, MD MSc Assistant Professor of Medicine

Responsible Party: Sushmita Pamidi, Clinician Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03167684     History of Changes
Other Study ID Numbers: 2017-2769
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Towards meta-analysis data

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases