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Myofunctional Therapy for Obstructive Sleep Apnea and Snoring
N/A
Recruiting
Led By Umesh Goswami, MBBS, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of mild to moderate obstructive sleep apnea with Apnea Hypopnea Index 5-29 events/hour confirmed within last 2 years with an in-lab diagnostic polysomnography or home sleep apnea test
Age greater than or equal to 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights
Study Summary
This trial will test whether a daily myofunctional therapy regimen can improve sleep apnea and primary snoring.
Who is the study for?
This trial is for adults over 18 with mild to moderate Obstructive Sleep Apnea (OSA) and snoring, who have a smartphone to log water intake. They must stop any OSA treatments three days before the study. Excluded are those with significant weight changes, excessive daytime sleepiness despite treatment, major health issues affecting fluid intake or upper airway anatomy due to surgeries or conditions like Down's Syndrome.Check my eligibility
What is being tested?
The study tests if using a myofunctional therapy (MT) nozzle on a water bottle daily can improve OSA and snoring compared to a placebo nozzle. Participants will use their assigned nozzles regularly and track their water consumption through an app.See study design
What are the potential side effects?
Since this trial involves non-invasive myofunctional therapy via a special water bottle nozzle, side effects may be minimal but could include jaw discomfort or fatigue from the exercises involved in the therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mild to moderate sleep apnea in the last 2 years.
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I am 18 years old or older.
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I own a smartphone and am willing to use an app to track my daily water intake.
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I am willing and able to stop my current sleep apnea treatment for 3 days before testing.
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I have mild to moderate sleep apnea and I snore.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to Therapy
Change in quality of life
Secondary outcome measures
Change in Apnea Hypopnea Index
Myofunction Assessment
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Myofunctional therapy (MT) nozzleExperimental Treatment1 Intervention
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily
Group II: Placebo nozzlePlacebo Group1 Intervention
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily
Find a Location
Who is running the clinical trial?
Remastered Sleep LLCUNKNOWN
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,317 Total Patients Enrolled
1 Trials studying Snoring
453 Patients Enrolled for Snoring
Mayo ClinicLead Sponsor
3,190 Previous Clinical Trials
3,758,057 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with mild to moderate sleep apnea in the last 2 years.I have had surgery on my throat or mouth that changed its shape.I have mild to moderate sleep apnea and I snore.I am 18 years old or older.I own a smartphone and am willing to use an app to track my daily water intake.I am willing and able to stop my current sleep apnea treatment for 3 days before testing.I have a condition like Down's Syndrome that affects my mouth or throat.I have mild to moderate sleep apnea and I snore.I do not have Obstructive Sleep Apnea but I snore.My weight has changed by 10% since my sleep apnea diagnosis.I still feel very sleepy during the day even though I'm treating my sleep apnea.I have serious health issues that limit how much I can drink.Your body mass index (BMI) is higher than 40.I am using a device to treat my sleep apnea.
Research Study Groups:
This trial has the following groups:- Group 1: Myofunctional therapy (MT) nozzle
- Group 2: Placebo nozzle
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to join this clinical trial at the current time?
"No, this study is not currently looking for new patients. The listing on clinicaltrials.gov shows that recruitment for this trial wrapped up on October 25th, 2022. There are, however, 250 other trials that are presently recruiting."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Mayo Clinic in Arizona
Mayo Clinic in Rochester
Why did patients apply to this trial?
I have had two sleep studies and was diagnosed with moderate sleep apnea but can't sleep with a CPAP device. I'm tired and I'd like to be able to get a restful night's sleep and not always feel fatigued.
PatientReceived no prior treatments
I have tried nasal strips, nose devices, mouth devices and have Inspire and cannot retain the appliances all night and inspire has not helped snoring. I will not use inspire for the duration of this today.
PatientReceived 2+ prior treatments
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