LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults
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|ClinicalTrials.gov Identifier: NCT04129229|
Recruitment Status : Enrolling by invitation
First Posted : October 16, 2019
Last Update Posted : January 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Snoring||Device: LinguaFlex Tongue Retractor (LTR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 10, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: LTR Treatment
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.
Device: LinguaFlex Tongue Retractor (LTR)
The LinguaFlex Tongue Retractor (LTR) is a small, flexible, implanted tongue retaining device that prevents 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.
- Responder to Therapy [ Time Frame: 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.
- Change in Epworth Sleepiness Scale (ESS) [ Time Frame: One Year ]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 [ Time Frame: One Year ]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.
- Quality of Life Metric - Pain [ Time Frame: At each follow-up visit over the course of 1 year ]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.
- Quality of Life Metric - Speech and Swallowing [ Time Frame: At each follow-up visit over the course of 1 year. ]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.
- Quality of Life Metric - Snoring [ Time Frame: At each follow-up visit over the course of 1 year. ]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 - 34; with 0 representing no snoring and 34 representing the worst possible snoring. The Spouse Bed Partner Survey is a series of 3 questions with a score range of 0 - 12; with a score of 0 representing no snoring and 12 the worst possible snoring.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129229
|United States, Massachusetts|
|St. Elizabeth's Medical Center|
|Brighton, Massachusetts, United States, 02135|
|United States, West Virginia|
|WVU Medicine / J. W. Ruby Memorial Hospitl|
|Morgantown, West Virginia, United States, 26505|
|Principal Investigator:||Peter Catalano, MD||Saint Elizabeth's Medical Center|