LTR for Treatment of Obstructive Sleep Apnea

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03066765

Enrollment

Registered

2017-02-28

Start date

2016-02-25

Completion date

2018-02-05

Last updated

2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

Study of tongue implant for treatment of obstructive sleep apnea

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.

Interventions

DEVICELinguaflex Tongue Retractor

Tongue implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026