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Oral Appliances for Obstructive Sleep Apnea (TACO Trial)
N/A
Recruiting
Led By Benjamin T Pliska, DDS
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
8 or more teeth per arch to support treatment with OAM
Treatment naive (have never used an oral appliance as treatment for OSA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data collected at 0, 18 and 36 months after appliance insertion.
Awards & highlights
TACO Trial Summary
This trial will compare the teeth positioning changes of people using a mouthpiece for sleep apnea with and without a morning mouth guard.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the appliances, possible soreness in the jaw muscles or temporomandibular joint (TMJ), saliva buildup or dry mouth while sleeping.
TACO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least 8 teeth in each jaw.
Select...
I have never used an oral appliance for sleep apnea.
TACO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ data collected at 0, 18 and 36 months after appliance insertion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collected at 0, 18 and 36 months after appliance insertion.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Overjet
Secondary outcome measures
Anterior Occlusal Changes
Change in Overbite
Daytime Sleepiness
+6 moreTACO Trial Design
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.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,467,013 Total Patients Enrolled
Université de MontréalOTHER
214 Previous Clinical Trials
102,666 Total Patients Enrolled
Laval UniversityOTHER
417 Previous Clinical Trials
172,167 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot move my jaw forward.I have kidney failure and need dialysis.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.My heart condition has been stable for at least 6 months.I have a history of heart issues like angina, heart attack, or stroke.I have severe gum disease with loose teeth.I have been in remission for over a year.Your mouth doesn't open wide enough for the treatment.I have never used an oral appliance for sleep apnea.I have a history of major depression and it is currently moderate to severe.I do not have severe heart failure that would make it unsafe for me to join the trial.Your body mass index (BMI) is less than or equal to 35.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Positive Control Group
- Group 3: Negative Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I be eligible to participate in this clinical experiment?
"This trial is recruiting 105 patients suffering from sleep apnea, obstructive who are within the age limit of 25 to 65."
Answered by AI
What is the aggregate size of the population involved in this trial?
"Absolutely. Data found on clinicaltrials.gov demonstrates that this medical trial, which was inaugurated on August 22nd 2018, is actively recruiting candidates. Specifically 105 participants are being sought out from a single location to take part in the experimentations."
Answered by AI
Are there any vacancies yet in this medical trial?
"The trial is actively enrolling, according to the records on clinicaltrials.gov, which first posted this study in August of 2018 and last updated it November 17th 2022."
Answered by AI
Does this medical trial permit individuals who are aged 75 and over to join?
"To be considered for the trial, prospective participants must meet an age criterion of 25 to 65 years old. For younger individuals aged 18 and below, there are 37 other trials available while 191 additional clinical studies exist for those above 65."
Answered by AI
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