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Mandibular Advancement Device

Somnodent for Obstructive Sleep Apnea (OSApod Trial)

N/A
Waitlist Available
Led By Sushmita Pamidi, MD
Research Sponsored by Université de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

OSApod Trial Summary

Issue: The prevalence and severity of sleep-disordered breathing increases during pregnancy due to weight gain, physiological and hormonal changes. These sleep breathing disorders have a negative impact on perinatal health for both the mother and the child.The optimal treatment of obstructive sleep apnea in pregnancy is unknown. Although CPAP therapy is often the treatment of choice, the mandibular advancement appliance would be an interesting alternative to solve the matter. Objectives: The main objective of this pilot study is to evaluate the feasibility of mandibular advancement device to treat sleep apnea during the 2nd and 3rd trimesters of pregnancy. Secondary objectives will be tools to plan a future randomized controlled trial to determine the efficacy of this treatment.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Pregnancy

OSApod Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
obstructive sleep apnea
Secondary outcome measures
adherence

OSApod Trial Design

1Treatment groups
Experimental Treatment
Group I: SomnodentExperimental Treatment1 Intervention
SomnoDent is a custom-made oral appliance for the treatment of mild to moderate obstructive sleep apnea. SomnoDent is worn during sleep to provide Continuous Open Airway Therapy by moving the lower jaw slightly forward. This movement tightens the soft tissue and muscles of the upper airway, which prevents obstructive apneas while sleeping.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somnodent
2016
N/A
~20

Find a Location

Who is running the clinical trial?

Université de MontréalLead Sponsor
214 Previous Clinical Trials
102,754 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
443 Previous Clinical Trials
159,481 Total Patients Enrolled
Sushmita Pamidi, MDPrincipal InvestigatorMcGill University

Frequently Asked Questions

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~2 spots leftby Apr 2025