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Behavioural Intervention

Treatment Group for Obstructive Sleep Apnea (DOT Trial)

N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the duration of dual therapy treatment (1 month).
Awards & highlights
No Placebo-Only Group

Summary

Continuous positive airway pressure (CPAP) is considered the gold standard therapy for obstructive sleep apnea (OSA). However, CPAP users sometimes experience pressure-related discomfort. It is thought that lower CPAP pressure may increase comfort and lead to greater treatment adherence. Mandibular advancement splint (MAS) therapy has been shown to be the preferred OSA treatment option among patients. However, MAS therapy is only partially effective in some OSA patients, especially in severe cases. It is thought that a combination of MAS and PAP therapy may benefit patients in which MAS alone is only partially effective. Using MAS and PAP at the same time is called "Dual Therapy". Dual Therapy may allow a lower CPAP pressure to be applied, which may increase patient comfort and therefore increase treatment adherence and overall effectiveness. This study will evaluate the effectiveness of 1 month of Dual Therapy in 30 OSA patients.

Eligible Conditions
  • Obstructive Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the duration of dual therapy treatment (1 month).
This trial's timeline: 3 weeks for screening, Varies for treatment, and the duration of dual therapy treatment (1 month). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Continuous Positive Airway Pressure
Comfort
Treatment Adherence (% nights)
+1 more
Secondary study objectives
Daytime Sleepiness
Efficacy - Minimum Saturation
Efficacy - Oxygen Desaturation Index
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
This group will undergo 1 month Dual Therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dual Therapy
2019
Completed Phase 4
~550

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,465 Previous Clinical Trials
2,485,467 Total Patients Enrolled
Université de MontréalOTHER
221 Previous Clinical Trials
104,250 Total Patients Enrolled
~4 spots leftby Nov 2025