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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
Must not have
Previous upper airway surgeries significantly modifying upper airway anatomy such as UPPP, apnea surgeries, oral and throat cancer surgeries or radiation
Known congenital or acquired diseases significantly affecting upper airway anatomy such as Down's Syndrome, oral and throat cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights

Summary

This trial is testing whether using a special device for mouth and throat exercises can help people with sleep apnea and snoring. The device aims to strengthen these muscles to keep the airway open during sleep.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery on my throat or mouth that changed its shape.
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I have a condition like Down's Syndrome that affects my mouth or throat.
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I do not have Obstructive Sleep Apnea but I snore.
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My weight has changed by 10% since my sleep apnea diagnosis.
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I still feel very sleepy during the day even though I'm treating my sleep apnea.
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I have serious health issues that limit how much I can drink.
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I am using a device to treat my sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to Therapy
Change in quality of life
Secondary study objectives
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for snoring include continuous positive airway pressure (CPAP), oral appliances, and myofunctional therapy. CPAP works by keeping the airway open with a steady stream of air, while oral appliances reposition the jaw or tongue to prevent airway obstruction. Myofunctional therapy, such as the use of a myofunctional therapy nozzle, involves repetitive resistance training to strengthen the muscles of the oropharyngeal region, including the tongue and soft palate. This improved muscle tone helps maintain airway patency during sleep, reducing the likelihood of snoring. Strengthening these muscles is crucial for snoring patients as it addresses the root cause of airway collapse, offering a non-invasive and potentially long-term solution.
Respiratory Muscle Training Reduces Respiratory Complications and Improves Swallowing Function After Stroke: A Systematic Review and Meta-Analysis.Response of genioglossus muscle activity to nasal airway occlusion in normal sleeping adults.Electrical stimulation of the lingual musculature in obstructive sleep apnea.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,909 Previous Clinical Trials
47,756,278 Total Patients Enrolled
1 Trials studying Snoring
453 Patients Enrolled for Snoring
Remastered Sleep LLCUNKNOWN
Mayo ClinicLead Sponsor
3,312 Previous Clinical Trials
2,954,529 Total Patients Enrolled

Media Library

Myofunctional therapy (MT) nozzle (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05371509 — N/A
Snoring Research Study Groups: Myofunctional therapy (MT) nozzle, Placebo nozzle
Snoring Clinical Trial 2023: Myofunctional therapy (MT) nozzle Highlights & Side Effects. Trial Name: NCT05371509 — N/A
Myofunctional therapy (MT) nozzle (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05371509 — N/A
~0 spots leftby Nov 2024