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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at each follow-up visit over the course of 1 year
Awards & highlights
Study Summary
This trial will study whether the LinguaFlex™ Tongue Retractor (LTR) device can reduce Obstructive Sleep Apnea (OSA) by keeping the tongue from blocking the airway during sleep.
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.Check my eligibility
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.See study design
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 belowSelect...
I agree not to use any sleep apnea treatments other than the study's during its course.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at each follow-up visit over the course of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at each follow-up visit over the course of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Responder to Therapy
Secondary outcome measures
Change in Epworth Sleepiness Scale (ESS)
Oxygen Desaturation Index (ODI) Responder
Other outcome measures
Pain
Quality of Life Metric - Snoring
Quality of Life Metric - Speech and Swallowing
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.
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Who is running the clinical trial?
Linguaflex, Inc.Lead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
Peter Catalano, MDPrincipal InvestigatorSaint Elizabeth's Medical Center
5 Previous Clinical Trials
359 Total Patients Enrolled
Ira Sanders, MDStudy DirectorLinguaflex, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have mild sleep apnea with an Apnea-Hypopnea Index (AHI) of less than 15.I am 18 or older with moderate to severe sleep apnea.I was born with a malformation in my upper airway or mouth area.I agree not to use any sleep apnea treatments other than the study's during its course.My tonsils are significantly enlarged.I have a blocked nose as confirmed by a doctor.I have had radiation therapy to my neck or upper respiratory area.I am not pregnant.You have a tongue stud or piercing already in place.You have severe sleep apnea with more than 50 breathing interruptions per hour.I am 18 or older with moderate to severe sleep apnea.I do not have serious heart or lung conditions.I do not have bleeding disorders, unresolved immune issues, or recent heart attacks.You have more than 20% of your AHI score accounted for by central apnea.I need to use extra oxygen regularly.I have completed treatment with PAP therapy as prescribed.I am under 18 years old.My oxygen levels drop below 70% for more than 10% of my sleep.You are allergic to silicone, PEEK, or polyurethane materials used in the study.I might have a blockage in my throat above the voice box.
Research Study Groups:
This trial has the following groups:- Group 1: LTR Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT04129229 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies within the scope of this study for participants?
"The information available on clinicaltrials.gov suggests that recruitment for this trial has ended. Although the study was initially posted in January 2020 and last updated on November 2022, 287 other studies are presently still looking to enroll new participants."
Answered by AI
Who else is applying?
What state do they live in?
West Virginia
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
WVU Medicine / J. W. Ruby Memorial Hospital
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I've been using CPAP for awhile and find it difficult. Uncomfortable. Restrictive. I would like to learn more about this device and trial.
PatientReceived 1 prior treatment
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