Treatment Group for Obstructive Sleep Apnea

University of British Columbia, Vancouver, Canada
Obstructive Sleep ApneaMandibular Repositioning Splint - Device
Eligibility
25 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the teeth positioning changes of people using a mouthpiece for sleep apnea with and without a morning mouth guard.

Eligible Conditions
  • Obstructive Sleep Apnea

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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passive myofunctional appliance
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Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Data collected at 0, 18 and 36 months after appliance insertion.

Month 36
Daytime Sleepiness
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Month 36
Anterior Occlusal Changes
Change in Overbite
Change in Overjet
Dental Crowding
Intercanine Distance
Intermolar Distance
Posterior Occlusal Changes
Month 36
Treatment Adherence

Trial Safety

Phase-Based Safety

1 of 3

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1
passive myofunctional appliance
2
Venlafaxine
3
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Negative Control Group
1 of 3
Treatment Group
1 of 3
Positive Control Group
1 of 3

Active Control

Experimental Treatment

105 Total Participants · 3 Treatment Groups

Primary Treatment: Treatment Group · No Placebo Group · N/A

Treatment GroupExperimental Group · 2 Interventions: Mandibular Repositioning Splint, Mandibular Advancement Oral Appliance · Intervention Types: Device, Device
Positive Control Group
Device
Experimental Group · 1 Intervention: Mandibular Advancement Oral Appliance · Intervention Types: Device
Negative Control GroupNoIntervention Group · 1 Intervention: Negative Control Group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: data collected at 0, 18 and 36 months after appliance insertion.

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,351 Previous Clinical Trials
1,564,484 Total Patients Enrolled
Laval UniversityOTHER
396 Previous Clinical Trials
166,561 Total Patients Enrolled
Université de MontréalOTHER
198 Previous Clinical Trials
95,652 Total Patients Enrolled
Benjamin T Pliska, DDSPrincipal InvestigatorUniversity British Columbia
1 Previous Clinical Trials
3 Total Patients Enrolled

Eligibility Criteria

Age 25 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have at least 8 teeth in each row of your mouth to be eligible for the treatment.
You need to have a body mass index (BMI) of 35 or less.
You have never used a dental device to treat your sleep apnea before.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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