Non-Randomized, Multi-Site, Single-Arm Study of the LinguaFlex™ Tongue Retractor (LTR) for the Treatment of Moderate to Severe Obstructive Sleep Apnea and Snoring in Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Responder to Therapy
研究概览
简要总结
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 sleep so that the tongue doesn't block the airway causing obstructive apnea or narrow it enough to cause snoring. This study will monitor the effectiveness of the LTR device in the reduction of Obstructive Sleep Apnea and snoring over the course of a one-year treatment period.
详细描述
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 study inclusion. The screening will consist of a Home Sleep Test (HST) completed within four (4) 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. Participation in the study is voluntary. Subjects may withdraw at any time during the study. Reasons for the withdrawal will be recorded and entered into the clinical study report. Any subject who withdraws from the study for any reason will have the device removed and will undergo a Post Device Removal Follow-Up within 30 days (-7/+ 15) of device removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Responder to Therapy
时间窗: One Year
Determine the responder rate to therapy. A responder is defined as a subject who experiences a ≥ 50% reduction in AHI from baseline and has an AHI \< 20 at the 12-month follow-up visit. Subjects with an AHI ≤ 20 at baseline will be considered a responder if a 50% reduction in AHI is achieved from baseline.
次要结局
- Change in Epworth Sleepiness Scale (ESS)(One Year)
- Oxygen Desaturation Index (ODI) Responder(One Year)