Obstructive Sleep ApneaNCT04129229
LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults
A study testing LinguaFlex Tongue Retractor (LTR) in people with Obstructive Sleep Apnea and Snoring, run by Linguaflex, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Snoring
- What is being tested?
- LinguaFlex Tongue Retractor (LTR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jan 2020to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 20Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
WVU Medicine / J. W. Ruby Memorial Hospital
Morgantown, West Virginia, 26505
About this study
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
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Snoring
- Being tested
- LinguaFlex Tongue Retractor (LTR)
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinguaFlex Tongue Retractor (LTR)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| LTR Treatment | Experimental | 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. Receives: Device: LinguaFlex Tongue Retractor (LTR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Year
Secondary outcomes (2)
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.)
Measured: One Year
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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start10 Jan 2020
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linguaflex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ira Sanders, MD, Study director, Linguaflex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129229
- Sponsor's protocol ID
- LTR-006-V02.0-US-CTP
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2019
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04129229
- Acronym / sponsor ID
- LTR-006-V02.0-US-CTP
- Conditions
- Obstructive Sleep Apnea, Snoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Linguaflex, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LTR Treatment | Experimental | Device: LinguaFlex Tongue Retractor (LTR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects able to read, understand and sign consent
- Subjects 18 years or older with:
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinguaFlex Tongue Retractor (LTR)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. | Device | LTR Treatment |
Primary outcome
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.
2 secondary outcomes
Change in Epworth Sleepiness Scale (ESS)
Time frame: One Year
Oxygen Desaturation Index (ODI) Responder
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No. No data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Sanders, MD study director
Linguaflex, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LinguaFlex Tongue Retractor (LTR) in people with Obstructive Sleep Apnea and Snoring, run by Linguaflex, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder to Therapy (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.