LTR for Obstructive Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a device called the LinguaFlex™ Tongue Retractor, which is placed in the tongue to help keep the airway open during sleep. It targets adults with moderate to severe sleep apnea. By preventing the tongue from blocking the airway, it aims to reduce snoring and sleep apnea episodes.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must agree not to use any additional therapy for sleep apnea during the study.
Is the LinguaFlex Tongue Retractor (LTR) safe for humans?
The safety of tongue suspension devices, like the LinguaFlex Tongue Retractor, has been studied in various forms. Some studies have shown promising results, but issues like device fracture, slippage, or migration have been noted. In animal studies, certain materials used in these devices have shown the ability to remodel into a strong, tendon-like structure over time.12345
What data supports the effectiveness of the treatment LinguaFlex Tongue Retractor (LTR) for obstructive sleep apnea?
Research on similar treatments, like the Mandibular-Lingual Repositioning Device (MLRD), shows significant improvement in sleepiness and overall condition in patients with obstructive sleep apnea. Additionally, techniques that control tongue position, such as tongue retention components, have been found effective in maintaining open airways during sleep.25678
Who Is on the Research Team?
Ira Sanders, MD
Principal Investigator
Linguaflex, Inc.
Are You a Good Fit for This Trial?
Adults over 18 with moderate to severe Obstructive Sleep Apnea (OSA) who have an AHI score of 15-50 and haven't found success with PAP therapy can join. They must not use other OSA treatments during the study, be able to consent, and not be pregnant or have certain medical conditions like heart failure or bleeding disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the LinguaFlex Tongue Retractor device and are monitored over the course of 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of sleepiness, pain, speech, swallowing, and snoring
What Are the Treatments Tested in This Trial?
Interventions
- LinguaFlex Tongue Retractor (LTR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Linguaflex, Inc.
Lead Sponsor