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Behavioural Intervention

Dental Device for Sleep Apnea During Pregnancy (OBMAD Trial)

N/A
Recruiting
Led By Miriam Jaziri, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18, English-speaking
BMI less or equal to 40 and neck size less or equal to 40 cm
Must not have
Unable to provide informed consent
Significant acute health problems unrelated to pregnancy or dental diseases including unstable psychiatric disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the use of a dental device called MAD in 10 pregnant women with mild-to-moderate sleep apnea. The study will look at how well the device works in improving

Who is the study for?
This trial is for pregnant women who have mild-to-moderate obstructive sleep apnea (OSA). The study aims to enroll 10 participants. Specific eligibility criteria are not provided, but typically, trials require participants to meet certain health standards and exclude those with conditions that could interfere with the study or pose a risk.
What is being tested?
The trial is testing the use of a Mandibular Advancement Device (MAD) in pregnant women with OSA. It's a single-arm study, meaning all participants will receive the MAD treatment. Their symptoms and sleep quality will be monitored before, during (for 10 weeks), and after pregnancy.
What are the potential side effects?
While specific side effects are not listed for this device, common issues may include discomfort in the jaw, teeth or gums; excessive salivation or dry mouth; temporary changes in bite alignment; and potential aggravation of temporomandibular joint disorder.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and speak English.
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My BMI is 40 or less and my neck size is 40 cm or smaller.
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I have good oral health and at least 8 teeth in each jaw.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand and agree to the study's details on my own.
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I do not have any severe health issues unrelated to pregnancy or dental problems.
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I do not speak English.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Describe patient uptake of MAD
Evaluate preliminary efficacy of MAD for treating mild-to-moderate OSA
Test for changes in patient-reported symptoms.

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: InterventionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,356 Total Patients Enrolled
Miriam Jaziri, MDPrincipal InvestigatorHenry Ford Hospital
~1 spots leftby Dec 2024
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