What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) that prevent the backward movement of the tongue or keep the airway open include tongue-stabilizing devices, mandibular advancement devices, and surgical interventions. Tongue-stabilizing devices can cause discomfort, excessive salivation, and dry mouth. Mandibular advancement devices may lead to jaw pain, dental discomfort, and temporomandibular joint issues. Surgical options, such as repositioning of the salivary glands or submandibular duct ligation, can result in complications like dry mouth, difficulty swallowing, and changes in oral secretions. Pharmacologic treatments, though less common, can have side effects like dizziness, visual disturbances, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Obstructive Sleep Apnea (OSA) that focus on maintaining an open airway during sleep. One such treatment is the mandibular advancement device, which works by repositioning the lower jaw and tongue forward to prevent airway obstruction. This device has been shown to improve the Apnea Hypopnea Index and symptoms in a significant number of patients. Another similar approach involves the use of tongue-stabilizing devices, which hold the tongue in a forward position to keep the airway open. These treatments are akin to the investigational LinguaFlex™ Tongue Retractor, which also aims to reduce OSA and snoring by preventing the backward movement of the tongue.

What other types of research exist?

Promising novel alternatives to the LinguaFlex™ Tongue Retractor for Obstructive Sleep Apnea (OSA) patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in improving language recovery and may have applications in OSA by modulating neural activity. 2) Transoral Robotic Surgery (TORS), which offers a minimally invasive approach to remove obstructions in the airway. 3) Hypoglossal Nerve Stimulation (HGNS), a device that stimulates the hypoglossal nerve to maintain airway patency during sleep. These treatments are emerging as effective options for managing OSA and snoring.

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Device

LTR for Obstructive Sleep Apnea

N/A

Waitlist Available

Led By Peter Catalano, MD

Research Sponsored by Linguaflex, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study

Be older than 18 years old

Must not have

Congenital malformations of the upper airway, larynx, pharynx, oral cavity or tongue

Tonsillar hypertrophy ≥3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device called the LinguaFlex™ Tongue Retractor, which is placed in the tongue to help keep the airway open during sleep. It targets adults with moderate to severe sleep apnea. By preventing the tongue from blocking the airway, it aims to reduce snoring and sleep apnea episodes.

Who is the study for?

Adults over 18 with moderate to severe Obstructive Sleep Apnea (OSA) who have an AHI score of 15-50 and haven't found success with PAP therapy can join. They must not use other OSA treatments during the study, be able to consent, and not be pregnant or have certain medical conditions like heart failure or bleeding disorders.

What is being tested?

The trial is testing the LinguaFlex Tongue Retractor (LTR), a device inserted into the tongue to prevent it from blocking the airway during sleep. The goal is to see if it reduces symptoms of OSA and snoring over one year.

What are the potential side effects?

Potential side effects are not explicitly listed in this summary but may include discomfort or pain at the site of insertion, possible infection risk, and any reactions related to allergies against materials used in LTR such as Silicone, PEEK, Polyurethane.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to use any sleep apnea treatments other than the study's during its course.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was born with a malformation in my upper airway or mouth area.

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My tonsils are significantly enlarged.

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I have a blocked nose as confirmed by a doctor.

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I have had radiation therapy to my neck or upper respiratory area.

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I am not pregnant.

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I do not have serious heart or lung conditions.

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I do not have bleeding disorders, unresolved immune issues, or recent heart attacks.

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I need to use extra oxygen regularly.

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I have completed treatment with PAP therapy as prescribed.

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I am under 18 years old.

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My oxygen levels drop below 70% for more than 10% of my sleep.

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I might have a blockage in my throat above the voice box.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Responder to Therapy

Secondary study objectives

Change in Epworth Sleepiness Scale (ESS)

Oxygen Desaturation Index (ODI) Responder

Other study objectives

Pain

Quality of Life Metric - Snoring

Quality of Life Metric - Speech and Swallowing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LTR TreatmentExperimental Treatment1 Intervention

Eligible subjects will undergo insertion of the LTR device in their tongue. Initiation of treatment will occur 7 days post insertion procedure and will be monitored over the course of 1 year.

0 / 13Eligibility 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 Obstructive Sleep Apnea (OSA) work by maintaining an open airway during sleep. CPAP machines provide continuous positive air pressure to keep the airway from collapsing. Oral appliances, like mandibular advancement devices, reposition the jaw or tongue to prevent airway obstruction. The LinguaFlex™ Tongue Retractor, an investigational device, specifically prevents the tongue from moving backward, which helps keep the airway open. These treatments are vital for OSA patients as they reduce apneas, improve sleep quality, and mitigate the risk of complications such as cardiovascular issues and daytime sleepiness.