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

Launched by LINGUAFLEX, INC. · Oct 14, 2019

Keywords

ClinConnect Summary

The study design is a multi-site, prospective, open-label, non-randomized, single-arm clinical study to test the efficacy of the LinguaFlex Tongue Retractor for the treatment of moderate to severe Obstructive Sleep Apnea (OSA) (AHI ≥15 at baseline) in adult subjects in twelve (12) months of continuous use. The study will include three (3) investigational sites that will implant a maximum of eighty (80) subjects with the LTR. No single site is to perform more than 35 implants. After informed consent is obtained, eligible subjects (adults who have moderate to severe OSA) will be screened for ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects able to read, understand and sign consent
• * Subjects 18 years or older with:
• • 1. Moderate to severe OSA (AHI of ≥ 15 to ≤ 50 as determined by a Diagnostic PSG recording within 2 months of inclusion)
• • 2. Subject agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study
• Exclusion Criteria:
• 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
• • Subjects with an existing tongue stud/piercing
• • Females who are pregnant (anesthesia risk)
• • Allergy to LTR materials (Silicone, PEEK, Polyurethane)
• • Subjects who have in the surgeon's judgment unusual anatomy that would interfere with treatment or increase the risk for the procedure
• • Unable and/or unwilling to comply with study requirements