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OpenTrials
Completed

NCT Number: NCT03066765

LTR for Treatment of Obstructive Sleep Apnea

Study of tongue implant for treatment of obstructive sleep apnea

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linguaflex Tongue Retractor

Device

Tongue implant

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Linguaflex, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 28, 2017
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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