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Behavioural Intervention

Intervention for 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

OBMAD Trial 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.Check my eligibility

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.See study design

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.

OBMAD Trial 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.

OBMAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

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

Describe patient uptake of MAD

Evaluate preliminary efficacy of MAD for treating mild-to-moderate OSA

Test for changes in patient-reported symptoms.

OBMAD Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,872 Total Patients Enrolled

Miriam Jaziri, MDPrincipal InvestigatorHenry Ford Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to enroll in this ongoing clinical trial?

"The trial is actively seeking participants as indicated on clinicaltrials.gov. It was initially published on February 1st, 2024 and most recently revised on February 5th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mandibular Advancement Device (MAD) in Pregnant Women With Obstructive Sleep Apnea (OSA)

2024. "Mandibular Advancement Device (MAD) in Pregnant Women With Obstructive Sleep Apnea (OSA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06256640.

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