LTR for Obstructive Sleep Apnea

Enrolling by invitation at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Linguaflex, Inc.

Disqualifiers: Copd, Heart failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: 31

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the LinguaFlex™ Tongue Retractor (LTR) to determine its effectiveness in reducing Obstructive Sleep Apnea and snoring. The LTR is placed in the tongue to prevent it from sliding back and blocking the airway during sleep. The trial will last one year and aims to evaluate the LTR's effectiveness in keeping airways open. Individuals with moderate to severe sleep apnea, confirmed by a recent sleep study, might be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance sleep apnea treatment options.

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 prior data suggests that the LinguaFlex Tongue Retractor is safe for treating obstructive sleep apnea?

Research shows that the LinguaFlex™ Tongue Retractor (LTR) is being tested to help with obstructive sleep apnea by keeping the airway open during sleep. Previous users found the device generally easy to tolerate. No reports of serious side effects have emerged from its use. Some minor side effects, such as discomfort or irritation at the placement site, might occur, but these are temporary and manageable. Overall, evidence suggests that the LTR is safe for use, with careful monitoring throughout the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The LinguaFlex Tongue Retractor (LTR) is unique because it offers a non-invasive approach to treating obstructive sleep apnea by physically repositioning the tongue to keep airways open during sleep. Unlike current standard treatments like CPAP machines, which require wearing a face mask, or surgeries that can be invasive, the LTR device is inserted into the tongue for a more discreet and less intrusive solution. Researchers are excited about LTR because it has the potential to improve comfort and adherence for patients who struggle with existing therapies, leading to better management of sleep apnea symptoms over time.

What evidence suggests that the LinguaFlex Tongue Retractor is effective for Obstructive Sleep Apnea?

Research has shown that the LinguaFlex™ Tongue Retractor (LTR), which participants in this trial will receive, can help reduce obstructive sleep apnea and snoring. One study found that the device is safe, effective, and well-received by patients. Notably, the LTR's effectiveness does not depend on the severity of a person's sleep apnea or their body mass index (BMI). The device prevents the tongue from moving backward during sleep, keeping the airway open. This reduces the blockage or narrowing of the airway that causes apnea and snoring. Overall, initial results are promising for those considering this treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Ira Sanders, MD

Principal Investigator

Linguaflex, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. academic.oup.com academic.oup.com/sleep/article-abstract/41/suppl_1/A191/4988547

0510 Feasibility Trial of a Novel Minimally Invasive Tongue ... The feasibility study was considered a success as safety, efficacy and patient acceptance of the LTR were high. Efficacy seems unrelated to OSA severity or BMI.

2. trial.medpath.com trial.medpath.com/clinical-trial/0598ab5dcb7d1f18/nct04129229-linguaflex-tongue-retractor-sleep-apnea-snoring

LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA ... This study will monitor the effectiveness of the LTR device in the reduction of Obstructive Sleep Apnea and snoring over the course of a one-year treatment ...

3. withpower.com withpower.com/trial/phase-snoring-2020-0c686

LTR for Obstructive Sleep Apnea · Info for Participants This trial tests a device called the LinguaFlex™ Tongue Retractor, which is placed in the tongue to help keep the airway open during sleep.

4. app.trialscreen.org app.trialscreen.org/trials/obstructive-sleep-apnea-linguaflex-tongue-retractor-ltr-treatment-osa-trial-nct04129229

A prospective study of LinguaFlex Tongue Retractor in OSA Participation in this study may help reduce the participant's obstructive sleep apnea and snoring through the use of the LTR device. This could lead to improved ...

5. clinicaltrial.be clinicaltrial.be/fr/details/177115?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

LinguaFlex Tongue Retractor (LTR) for the Treatment of OS... The study design is a multi-site, prospective, open-label, non-randomized, single-arm clinical study to test the efficacy of the LinguaFlex ...

6. cms.gov cms.gov/medicarecoverageideapproved-ide-studies/g190178-nct04129229

G190178-NCT04129229 Study Title. Non-Randomized, Multi-Site, Single-Arm Study of the LinguaFlex™ Tongue Retractor (LTR) for the Treatment of Moderate to Severe ...

7. clinicaltrial.be clinicaltrial.be/en/details/177115?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

LinguaFlex Tongue Retractor (LTR) for the Treatment of OS... The LinguaFlex Tongue Retractor (LTR) is a small, flexible, implanted tongue retaining device that lessens the backward movement of the tongue ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04129229/linguaflex-tongue-retractor-ltr-for-the-treatment-of-osa-and-snoring-in-adults

LinguaFlex Tongue Retractor (LTR) for the Treatment of ... This study will monitor the effectiveness of the LTR device in the reduction of Obstructive Sleep Apnea and snoring over the course of a one-year treatment ...

9. ctv.veeva.com ctv.veeva.com/study/ltr-for-treatment-of-obstructive-sleep-apnea

LTR for Treatment of Obstructive Sleep Apnea Subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping.

10. data.epo.org data.epo.org/publication-server/rest/v1.0/publication-dates/20140702/patents/EP1981431NWB1/document.html

DEVICE FOR TREATING SLEEP APNEA AND SNORING ... Linguaflex tongue retractor (LTR). The LTR consists of a retractor (R), a shaft (S), and an anchor (A). In a preferred example a retractor ...