Non-Randomized, Multi-Site, Single-Arm Study of the LinguaFlex™ Tongue Retractor for the Treatment of Moderate to Severe Obstructive Sleep Apnea and Snoring in Adult Subjects (LTR™ Trial)
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 (LTR) 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 minimum of sixty (60) subjects with the LTR. No single site is to perform more than 25 implants. After informed consent is obtained, eligible subjects (adults who have moderate to severe OSA) will be screened for study inclusion. The screening will consist of a Polysomnography (PSG) completed within two (2) months of inclusion in the study to confirm the diagnosis of moderate to severe OSA, an Epworth Sleepiness Scale (ESS) assessment, Snoring Self-Assessment (SOS) with bed partner input (SBPS), assessment of pain, speech and swallowing, and a physical examination. The screening data will be reviewed by the Sponsor’s designated study monitor to confirm and approve that inclusion criteria are fully met. Failure to meet all inclusion criteria will be designated as a screen failure and the subject’s enrollment will be terminated.
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Subject able to read, understand and sign a consent
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Adults 18 years of age or greater with:
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Moderate to Severe Obstructive Sleep Apnea (AHI of >15 to < 50 as determined by a Diagnostic PSG recording within 2 months of inclusion)
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Subjects agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study
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- <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
- 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
*For a list of all eligibility criteria please contact the Study Team*
Steward Health Care