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Mandibular Advancement Device for Nocturia (MAD Trial)

N/A
Recruiting
Led By Fernanda Yanez Regonesi, DDS, MS
Research Sponsored by Fernanda Yanez Regonesi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18
Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Awards & highlights

MAD Trial Summary

This trial will test if using a MAD device is associated with less instances of nocturia (waking up to urinate at night).

Who is the study for?
This trial is for adults over 18 with obstructive sleep apnea (AHI≥5) who experience at least two trips to the bathroom per night. Participants must have ≥8 teeth per arch, be able to move their jaw forward by ≥5mm, and speak English. People can't join if they're pregnant, have certain medical conditions like heart failure or diabetes, use diuretics, or are already using other treatments for sleep apnea.Check my eligibility
What is being tested?
The study is examining whether a mandibular advancement device (MAD), specifically the Somnodent Classic model, can reduce nighttime urination (nocturia) in people with obstructive sleep apnea.See study design
What are the potential side effects?
Potential side effects of using a MAD may include discomfort in the jaw, teeth or gums; excessive salivation or dry mouth; temporary changes in bite alignment upon waking; and possible aggravation of temporomandibular joint disorders.

MAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.
Select...
I have at least 8 teeth in each jaw and can move my lower jaw forward by 5 mm or more.
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I have been diagnosed with obstructive sleep apnea.
Select...
I go to the bathroom to urinate 2 or more times at night.
Select...
I have at least 8 teeth per arch and can move my lower jaw forward by 5 mm.

MAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nocturia
Secondary outcome measures
Nocturia
Other outcome measures
Fatigue
Sleeplessness
Changes in quality of life

MAD Trial Design

1Treatment groups
Experimental Treatment
Group I: MAD therapyExperimental Treatment1 Intervention
MAD Therapy

Find a Location

Who is running the clinical trial?

Fernanda Yanez RegonesiLead Sponsor
American Academy of Dental Sleep MedicineUNKNOWN
Fernanda Yanez Regonesi, DDS, MSPrincipal InvestigatorUniversity Of Kentucy

Media Library

Somnodent Classic (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05562388 — N/A
Obstructive Sleep Apnea Research Study Groups: MAD therapy
Obstructive Sleep Apnea Clinical Trial 2023: Somnodent Classic Highlights & Side Effects. Trial Name: NCT05562388 — N/A
Somnodent Classic (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05562388 — N/A
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT05562388 — N/A

Frequently Asked Questions

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

What is the criteria for admission in this research experiment?

"This trial is seeking 36 English-speaking participants who are 18 years or older and suffer from nocturia. Furthermore, to be eligible for the study they must have ≥ 2 voiding/night at baseline, give their consent, possess a diagnosis of Obstructive sleep apnea with an AHI≥5, as well as have at least 8 teeth per arch with a range of mandibular protrusion ≥ 5mm on clinical examination."

Answered by AI

Does this trial provide the opportunity for participants under 20 years of age?

"This medical research study is currently open to participants aged 18 and above, with an upper limit of 80 years."

Answered by AI

Is there still space to enroll in this research endeavor?

"The clinical trial details hosted on clinicaltrials.gov indicate that this medical study is not looking for new participants at the moment; however, it was initially posted in February of 2023 and last updated in November of 2022. Alternatively, 293 other trials are actively recruiting patients right now."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Kentucky
Oregon
Other
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
3+

Why did patients apply to this trial?

Because I hate waking up during the night. I have dental implant based denture in lower jaw.
PatientReceived no prior treatments
I've been told by my sister and late brother in-law that I've stopped breathing while I slept, Also I fall asleep at work.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is there a trial in Houston, Texas?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Mandibular Advancement Device and Changes in Nocturia
Fernanda Yanez Regonesi 2023. "Mandibular Advancement Device and Changes in Nocturia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05562388.
~9 spots leftby Aug 2024
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