Back to resultsLinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults
Primary Purpose
Obstructive Sleep Apnea, Snoring
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LinguaFlex Tongue Retractor (LTR)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- 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 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
Sites / Locations
- St. Elizabeth's Medical Center
- WVU Medicine / J. W. Ruby Memorial Hospital
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LTR Treatment
Arm Description
Eligible subjects will undergo insertion of the LTR device in their tongue. Initiation of treatment will occur 7 days post insertion procedure and will be monitored over the course of 1 year.
Outcomes
Primary Outcome Measures
Responder to Therapy
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.
Secondary Outcome Measures
Change in Epworth Sleepiness Scale (ESS)
Determine the change in Epworth Sleepiness Scale (ESS) from the baseline control measurement and determine the proportion of study subjects that achieve an ESS value of ≤ 10 at the twelve-month follow-up. ((ESS is a validated instrument that rates a subject's daytime sleepiness and is commonly used in clinical evaluation and management of OSA as a quality of life measurement. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS < 10 is considered normal subjective sleepiness.)
Oxygen Desaturation Index (ODI) Responder
Determine the Oxygen Desaturation Index (ODI) responder rate at the twelve-month follow-up visit. An ODI responder is defined as a subject which demonstrates at least a 25% reduction in ODI from the baseline control measurement at the 12-month follow-up visit. Change in ODI will be reported as a percentage change from baseline for each subject as well as the mean percentage change for the entire cohort.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04129229
Brief Title
LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Linguaflex, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LTR Treatment
Arm Type
Experimental
Arm Description
Eligible subjects will undergo insertion of the LTR device in their tongue. Initiation of treatment will occur 7 days post insertion procedure and will be monitored over the course of 1 year.
Intervention Type
Device
Intervention Name(s)
LinguaFlex Tongue Retractor (LTR)
Intervention Description
The LinguaFlex Tongue Retractor (LTR) is a small, flexible, implanted tongue retaining device that lessens the backward movement of the tongue during sleep. The LTR's flexible shaft and a nubbed tether passes through the center of the tongue beneath the tongue blade (frenulum area) and connects to a disc (head) that rests on the external surface of the tongue base mucosa. Underneath the tongue, on the external surface of the frenulum, a small anchor secures the shaft that can be adjusted to tension the LTR to maximize therapeutic effect and maintain comfort.
Primary Outcome Measure Information:
Title
Responder to Therapy
Description
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.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Change in Epworth Sleepiness Scale (ESS)
Description
Determine the change in Epworth Sleepiness Scale (ESS) from the baseline control measurement and determine the proportion of study subjects that achieve an ESS value of ≤ 10 at the twelve-month follow-up. ((ESS is a validated instrument that rates a subject's daytime sleepiness and is commonly used in clinical evaluation and management of OSA as a quality of life measurement. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS < 10 is considered normal subjective sleepiness.)
Time Frame
One Year
Title
Oxygen Desaturation Index (ODI) Responder
Description
Determine the Oxygen Desaturation Index (ODI) responder rate at the twelve-month follow-up visit. An ODI responder is defined as a subject which demonstrates at least a 25% reduction in ODI from the baseline control measurement at the 12-month follow-up visit. Change in ODI will be reported as a percentage change from baseline for each subject as well as the mean percentage change for the entire cohort.
Time Frame
One Year
Other Pre-specified Outcome Measures:
Title
Quality of Life Metric - Pain
Description
Examine the tolerance and comfort of the implanted LTR. Pain will be assessed at each follow-up visit using a 10 point Visual Analog Scale (0 no pain - 10 worst pain) and will be compared to the baseline measurement.
Time Frame
At each follow-up visit over the course of 1 year
Title
Quality of Life Metric - Speech and Swallowing
Description
Examine the tolerance and comfort of the implanted LTR. Comfort with speech and swallowing will be assessed using the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN). This scale consists of three individual scores for Normalcy of Diet, Eating in Public and Understanding of Speech. In each case a score of 100 indicates normal function and 0 indicates the most limited function.
Time Frame
At each follow-up visit over the course of 1 year.
Title
Quality of Life Metric - Snoring
Description
Examine the change in snoring from the baseline control measurement. Snoring will be assessed using the Snore Outcome Survey (SOS) and the Spouse/Bed Partner Survey (SBPS). The SOS is a series of 8 questions with a score range of 0 - 100; with 0 representing the worst possible snoring and 100 representing no snoring. The Spouse Bed Partner Survey is a series of 3 questions with a score range of 0 - 100; with a score of 0 representing the worst possible snoring and 100 representing no snoring.
Time Frame
At each follow-up visit over the course of 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Sanders, MD
Organizational Affiliation
Linguaflex, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
WVU Medicine / J. W. Ruby Memorial Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared with other researchers.
Learn more about this trial
LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults
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