Status:
ENROLLING_BY_INVITATION
LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults
Lead Sponsor:
Linguaflex, Inc.
Conditions:
Obstructive Sleep Apnea
Snoring
Eligibility:
All Genders
18+ years
Phase:
NA
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 sle...
Detailed Description
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 Obs...
Eligibility Criteria
Inclusion
- Subjects able to read, understand and sign consent
- Subjects 18 years or older with:
- Moderate to severe OSA (AHI of ≥ 15 to ≤ 50 as determined by a Diagnostic PSG recording within 2 months of inclusion)
- Subject agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study
Exclusion
- 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
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04129229
Start Date
January 10 2020
End Date
April 1 2026
Last Update
October 9 2024
Active Locations (3)
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1
St. Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135
2
WVU Medicine / J. W. Ruby Memorial Hospital
Morgantown, West Virginia, United States, 26505
3
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226