Sleep Apnea, ObstructiveNCT03167684
Effect of Oral Appliance Therapy on Glucose Levels in Patients With T2DM and OSA: A Pilot Trial
A study testing Oral appliance therapy in people with Sleep Apnea, Obstructive and Type 2 Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Type 2 Diabetes Mellitus
- What is being tested?
- Oral appliance therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active and significant psychiatric disease
- BMI>35
- Regular use of sedatives or narcotics
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre - Research Institute
Montreal, Quebec, H4A2Y3
Sushmita Pamidi, MD
Sushmita Pamidi, MD
About this study
Official title: The Effect of Oral Appliance Therapy on Cardiometabolic Outcomes in Patients With Type 2 Diabetes and Obstructive Sleep Apnea: A Pilot RCT
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive, Type 2 Diabetes Mellitus
- Being tested
- Oral appliance therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral appliance therapyDevice
Also called Mandibular advancement device
Fitted oral appliance
| Study group | Role | What they receive |
|---|---|---|
| Oral appliance therapy | Experimental | Oral appliance (SomnoMed) worn nightly Receives: Device: Oral appliance therapy |
| Control | No intervention | Sham oral appliance device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rates
feasibility of study in T2DM
Measured: End of study (Week 20)
Glycemic control (mean 24-hour and nocturnal glucose)
24-hour continuous glucose monitoring
Measured: End of study (week 20)
Secondary outcomes (4)
Blood pressure
Measurement of clinic blood pressure
Measured: End of study (Week 20)
Glucose variability
Continuous glucose monitoring system (ipro2, Medtronic)
Measured: End of study (Week 20)
Changes in insulin or diabetes medication doses
Reporting of dose change by participant or treating physician.
Measured: End of study (Week 20)
Systemic inflammation
hs-CRP
Measured: End of study (Week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 May 2017
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Sushmita Pamidi, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Sushmita Pamidi, MD MSc, Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167684
- Sponsor's protocol ID
- 2017-2769
- Status last verified
- Sep 2017
- First submitted
- 21 May 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Towards meta-analysis data
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Appliance Therapy on Cardiometabolic Outcomes in Patients With Type 2 Diabetes and Obstructive Sleep Apnea: A Pilot RCT
- ClinicalTrials.gov ID
- NCT03167684
- Acronym / sponsor ID
- 2017-2769
- Conditions
- Sleep Apnea, Obstructive, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 1 May 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral appliance therapy | Experimental | Device: Oral appliance therapyOral appliance (SomnoMed) worn nightly |
| Control | No intervention | –Sham oral appliance device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral appliance therapyAlso: Mandibular advancement deviceFitted oral appliance | Device | Oral appliance therapy |
Primary outcome
Recruitment and retention rates
Time frame: End of study (Week 20)
feasibility of study in T2DM
Glycemic control (mean 24-hour and nocturnal glucose)
Time frame: End of study (week 20)
24-hour continuous glucose monitoring
4 secondary outcomes
Blood pressure
Time frame: End of study (Week 20)
Glucose variability
Time frame: End of study (Week 20)
Changes in insulin or diabetes medication doses
Time frame: End of study (Week 20)
Systemic inflammation
Time frame: End of study (Week 20)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: Yes. Towards meta-analysis data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushmita Pamidi, MD MSc principal investigator
Assistant Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral appliance therapy in people with Sleep Apnea, Obstructive and Type 2 Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sushmita Pamidi, MD MSc (514-934-1934 ext. 36479, sushmita.pamidi@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: End of study (Week 20)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.