What side effects are associated with this type of intervention?

Common treatments for snoring, such as myofunctional therapy, oral appliances, and positive airway pressure (PAP) therapy, have various side effects. Myofunctional therapy, which involves repetitive resistance training to improve muscle tone in the oropharyngeal region, may cause mild discomfort or soreness in the mouth and throat. Oral appliances, like mandibular advancement devices, can lead to jaw pain, dental discomfort, and excessive salivation. PAP therapy, while effective, often results in nasal congestion, dry mouth, and discomfort from the mask. These side effects are generally manageable and should be discussed with a healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

The FDA has approved various treatments for snoring, including oral appliances like mandibular advancement devices (MADs) that reposition the jaw to keep the airway open. These devices are similar to the Myofunctional Therapy Nozzle in that they aim to improve airway function, though they do so by mechanical repositioning rather than muscle training. Additionally, positive airway pressure (PAP) devices, which maintain airway patency through continuous airflow, have also been approved. While specific FDA approvals for myofunctional therapy devices targeting snoring are limited, the concept of improving muscle tone and function in the oropharyngeal region is a recognized approach in managing snoring and obstructive sleep apnea.

What other types of research exist?

Promising alternatives to Myofunctional Therapy Nozzle for snoring patients include Continuous Positive Airway Pressure (CPAP), which has been extensively studied and shown to be effective in treating OSA and snoring. Mandibular Advancement Devices (MADs) are also a viable option, as they have demonstrated efficacy in reducing snoring and improving sleep quality. Additionally, weight loss interventions and anti-inflammatory therapies, such as nasal steroids and leukotriene modifiers, have shown benefits in managing snoring and mild OSA.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

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

0 / 9Eligibility criteria met

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.