LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults

NCT04129229 | Enrolling By Invitation FDA Device

• 1 other identifier: LTR-006-V02.0-US-CTP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

The LinguaFlex™ Tongue Retractor (LTR) is an investigational medical device that is inserted into the tongue to lessen its backward movement during sleep. This helps to keep the airway open during sleep so that the tongue doesn't block the airway causing obstructive apnea or narrow it enough to cause snoring. 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 period.

Conditions

Obstructive Sleep Apnea; Snoring

Outcome Measures

Primary Outcomes (1)

• Responder to Therapy

  Determine the responder rate to therapy. A responder is defined as a subject who experiences a ≥ 50% reduction in AHI from baseline and has an AHI \< 20 at the 12-month follow-up visit. Subjects with an AHI ≤ 20 at baseline will be considered a responder if a 50% reduction in AHI is achieved from baseline.

  One Year

Secondary Outcomes (2)

• Change in Epworth Sleepiness Scale (ESS)

  One Year

• Oxygen Desaturation Index (ODI) Responder

  One Year

Other Outcomes (3)

• Quality of Life Metric - Pain

  At each follow-up visit over the course of 1 year

• Quality of Life Metric - Speech and Swallowing

  At each follow-up visit over the course of 1 year.

• Quality of Life Metric - Snoring

  At each follow-up visit over the course of 1 year.

Study Arms (1)

LTR Treatment

EXPERIMENTAL

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.

Device: LinguaFlex Tongue Retractor (LTR)

Interventions

LinguaFlex Tongue Retractor (LTR) DEVICE

The LinguaFlex Tongue Retractor (LTR) is a small, flexible, implanted tongue retaining device that lessens the backward movement of the tongue during sleep. The LTR's flexible shaft and a nubbed tether passes through the center of the tongue beneath the tongue blade (frenulum area) and connects to a disc (head) that rests on the external surface of the tongue base mucosa. Underneath the tongue, on the external surface of the frenulum, a small anchor secures the shaft that can be adjusted to tension the LTR to maximize therapeutic effect and maintain comfort.

LTR Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects able to read, understand and sign consent
• Subjects 18 years or older with:
• Subject agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from participation in the clinical trial:
• \< 18 years of age
• AHI \< 15(mild OSA)
• AHI \> 50
• Subjects with \> 20% of AHI score accounted for from central apnea
• More than 10% of Total Sleep Time (TST) with blood O2 saturation (SaO2) below 70%
• Subjects successfully treated with prescribed PAP therapy
• Tonsillar hypertrophy ≥3
• Subjects with significant active comorbid respiratory or cardiac disease (such as COPD or Heart Failure)
• Subjects requiring regular use of supplemental oxygen
• Nasal airway obstruction as seen on examination
• Congenital malformations of the upper airway, larynx, pharynx, oral cavity or tongue
• Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination (suspected epiglottic obstruction)
• History of radiation therapy to the neck or upper respiratory tract
• Subjects with bleeding disorders, unresolved impaired immunity for any reason, or heart attack within the last six months

Sponsors & Collaborators

• Linguaflex, Inc.: lead

Study Sites (3)

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

WVU Medicine / J. W. Ruby Memorial Hospital

Morgantown, West Virginia, 26505, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ira Sanders, MD

  Linguaflex, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 16, 2019
• Study Start: January 10, 2020
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)