LTR for Obstructive Sleep Apnea

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Linguaflex, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: 12 months

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must agree not to use any additional therapy for sleep apnea during the study.

What data supports the effectiveness of the treatment LinguaFlex Tongue Retractor (LTR) for obstructive sleep apnea?

Research on similar treatments, like the Mandibular-Lingual Repositioning Device (MLRD), shows significant improvement in sleepiness and overall condition in patients with obstructive sleep apnea. Additionally, techniques that control tongue position, such as tongue retention components, have been found effective in maintaining open airways during sleep. ^{1 2 3 4 5}

Is the LinguaFlex Tongue Retractor (LTR) safe for humans?

The safety of tongue suspension devices, like the LinguaFlex Tongue Retractor, has been studied in various forms. Some studies have shown promising results, but issues like device fracture, slippage, or migration have been noted. In animal studies, certain materials used in these devices have shown the ability to remodel into a strong, tendon-like structure over time. ^{2 4 6 7 8}

Research Team

Ira Sanders, MD

Principal Investigator

Linguaflex, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 or older with moderate to severe sleep apnea.

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

I am 18 or older with moderate to severe sleep apnea.

Exclusion Criteria

You have mild sleep apnea with an Apnea-Hypopnea Index (AHI) of less than 15.

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

My tonsils are significantly enlarged.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 months

1 visit (in-person)

Treatment

Participants receive the LinguaFlex Tongue Retractor device and are monitored over the course of 1 year

12 months

Regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of sleepiness, pain, speech, swallowing, and snoring

1 month

Post Device Removal Follow-Up within 30 days

Treatment Details

Interventions

• LinguaFlex Tongue Retractor (LTR)

Trial Overview 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.

Participant Groups

Group I: LTR Treatment Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Linguaflex, Inc.

Lead Sponsor

Trials

2

Recruited

100+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Mandibular-Lingual Repositioning Device--MLRD: preliminary results of 8 patients with obstructive sleep apnea syndrome--OSAS. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Suspension sutures for the treatment of obstructive sleep apnea and snoring. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A combination appliance for obstructive sleep apnea: the effectiveness of mandibular advancement and tongue retention. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Transoral robotic sleep surgery: the obstructive sleep apnea-hypopnea syndrome. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Multicenter study of a novel adjustable tongue-advancement device for obstructive sleep apnea. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Tendon-like tether formation for tongue-base advancement in an ovine model using a novel implant device intended for the surgical management of obstructive sleep apnoea. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Tongue base suspension and radiofrequency volume reduction: a comparison between 2 techniques for the treatment of sleep-disordered breathing. [2022]