LTR for Treatment of Obstructive Sleep Apnea

August 8, 2018 updated by: Linguaflex, Inc.

Non-Randomized, Single Arm Study of the New Linguaflex Tongue Retractor for the Treatment of Obstructive Sleep Apnea

Study of tongue implant for treatment of obstructive sleep apnea

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping. Subjects will be followed a year with primary endpoint of AHI results through Polysomnography readings (PSG) testing in an overnight sleep lab.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AHI>10
  • 18 years of age

Exclusion Criteria:

  • Subjects with >20% of their AHI accounted for from central apnea.
  • Mallampanti score of 4
  • Tonsillar hypertrophy (4+)
  • Prior uvulopalatopharyngoplasty (UPPP) procedure
  • Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination or x-ray
  • Tongue thickness <40 mm measured on lateral cephalogram x-ray from the frenulum to linea terminalis
  • More than 10% of sleep time with blood O2 desaturation below 70%
  • Unable and/or unwilling to comply with study requirements
  • Females of child bearing age who are pregnant or intending to become pregnant
  • Allergy to silicone
  • History of radiation therapy to neck or upper respiratory tract
  • Subjects with bleeding disorders, impaired immunity for any reason, or heart attack within the last six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LTR Treatment
An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy
Device: Linguaflex Tongue Retractor
Tongue implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing
Time Frame: 1 year
Recording of Apnea Hypopnea Index through polysomnography during overnight sleep study
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device
Time Frame: 1 year
Assessment of Adverse Events and Serious Adverse Events
1 year
Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale
Time Frame: 1 year
Assess level of sleepiness pre and post treatment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linguaflex, Inc.

Investigators

  • Principal Investigator: Balwinder Singh, MD, Putrajaya Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2016

Primary Completion (Actual)

November 21, 2017

Study Completion (Actual)

February 5, 2018

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTR-005-V01.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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