Oral Appliances for Obstructive Sleep Apnea
(TACO Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBenjamin T Pliska, DDS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of British Columbia

No Placebo Group

Trial Summary

What is the purpose of this trial?

Obstructive sleep apnea (OSA) is a sleep related breathing disorder, affecting approximately 10% of adults. Mandibular advancement oral appliances (OAM) are an effective treatment for OSA, however, long term use has shown to lead to changes in teeth positioning and jaw alignment (bite changes), which has resulted in some patients stopping treatment. It is becoming common clinical practice for doctors to prescribe the use of repositioning splints to help reduce the bite changes associated with using OAM. However, this has not been studied in a clinical trial. This study will compare the bite changes between patients using OAM alone against patients using a morning repositioning splint in addition to OAM. Other variables, such as oral health, the size of mandibular advancement, and treatment adherence will also be measured to determine if they have an effect on the bite changes associated with OAM use. By understanding the key the factors that influence the bite changes associated with OAM use and potentially validating a technique to reduce these changes, this study will improve the clinical practice of Dental Sleep Medicine, leading to improved health outcomes for OSA patients.

Research Team

Benjamin T Pliska, DDS

Principal Investigator

University British Columbia

Eligibility Criteria

This trial is for adults aged 25-65 with mild to moderate Obstructive Sleep Apnea, documented by specific sleep tests. Participants must have a BMI ≤ 35, at least 8 teeth per arch, and no prior OAM treatment for OSA. Exclusions include severe dental or jaw issues, pregnancy, major depression with current severe disease, certain heart conditions, stroke history, and active cancer unless in remission.

Inclusion Criteria

I am between 25 and 65 years old and can give consent.

I have at least 8 teeth in each jaw.

You have had a sleep test that showed you have moderate to severe breathing problems during sleep.

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Exclusion Criteria

I cannot move my jaw forward.

I have kidney failure and need dialysis.

Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study)

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Treatment Details

Interventions

Mandibular Advancement Oral Appliance (Procedure)
Mandibular Repositioning Splint (Procedure)

Trial OverviewThe study examines if using a morning repositioning splint along with an oral appliance (OAM) reduces bite changes compared to using just the OAM in treating sleep apnea. It will also assess how factors like oral health and the extent of mandibular advancement affect these potential changes.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment2 Interventions

The treatment group will will be treated a mandibular advancement oral appliance following standard practices. The treatment group will also receive a mandibular repositioning splint to wear in the mornings for a minimum of 1 hour following removal of their mandibular advancement oral appliance, in an effort to reduce the side effects resulting from use of the mandibular advancement oral appliance.

Group II: Positive Control GroupExperimental Treatment1 Intervention

The positive control group will will be treated a mandibular advancement oral appliance following standard practices. The positive control group will not receive any additional oral appliances. Side effects resulting from use of the mandibular advancement oral appliance will be managed using standard practices, including jaw stretching exercises as needed for comfort.

Group III: Negative Control GroupActive Control1 Intervention

The negative control group is comprised of 15 healthy individuals recruited specifically from faculty members at the UBC Faculty of Dentistry. This group will undergo the same clinical data collection as the treatment group and the negative control group but will not receive any treatment.