Obstructive Sleep ApneaNCT03066765
LTR for Treatment of Obstructive Sleep Apnea
A study testing Linguaflex Tongue Retractor in people with Obstructive Sleep Apnea, run by Linguaflex, Inc..
Trial summary
Study of tongue implant for treatment of obstructive sleep apnea Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Linguaflex Tongue Retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2016to 5 Feb 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AHI>10
- 18 years of age
Who cannot join
- Subjects with >20% of their AHI accounted for from central apnea.
- Mallampanti score of 4
- Tonsillar hypertrophy (4+)
- Prior uvulopalatopharyngoplasty (UPPP) procedure
- Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination or x-ray
- Tongue thickness <40 mm measured on lateral cephalogram x-ray from the frenulum to linea terminalis
Show all 12Show fewer
- More than 10% of sleep time with blood O2 desaturation below 70%
- Unable and/or unwilling to comply with study requirements
- Females of child bearing age who are pregnant or intending to become pregnant
- Allergy to silicone
- History of radiation therapy to neck or upper respiratory tract
- Subjects with bleeding disorders, impaired immunity for any reason, or heart attack within the last six months
About this study
Official title: Non-Randomized, Single Arm Study of the New Linguaflex Tongue Retractor for the Treatment of Obstructive Sleep Apnea
Study of tongue implant for treatment of obstructive sleep apnea
Read the detailed description
Subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping. Subjects will be followed a year with primary endpoint of AHI results through Polysomnography readings (PSG) testing in an overnight sleep lab.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Linguaflex Tongue Retractor
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linguaflex Tongue RetractorDevice
Tongue implant
| Study group | Role | What they receive |
|---|---|---|
| LTR Treatment | Experimental | An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy Receives: Device: Linguaflex Tongue Retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing
Recording of Apnea Hypopnea Index through polysomnography during overnight sleep study
Measured: 1 year
Secondary outcomes (2)
Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device
Assessment of Adverse Events and Serious Adverse Events
Measured: 1 year
Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale
Assess level of sleepiness pre and post treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start25 Feb 2016
- Primary completion21 Nov 2017
- Study completion5 Feb 2018
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linguaflex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balwinder Singh, MD, Principal investigator, Putrajaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066765
- Sponsor's protocol ID
- LTR-005-V01.2
- Status last verified
- Aug 2018
- First submitted
- 23 Feb 2017
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Randomized, Single Arm Study of the New Linguaflex Tongue Retractor for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03066765
- Acronym / sponsor ID
- LTR-005-V01.2
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Linguaflex, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 28 Feb 2017 (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.
Study of tongue implant for treatment of obstructive sleep apnea
Detailed description
Subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping. Subjects will be followed a year with primary endpoint of AHI results through Polysomnography readings (PSG) testing in an overnight sleep lab.
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 RetractorAn implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AHI>10
- 18 years of age
Key exclusion criteria (12 listed)
- Subjects with >20% of their AHI accounted for from central apnea.
- Mallampanti score of 4
- Tonsillar hypertrophy (4+)
- Prior uvulopalatopharyngoplasty (UPPP) procedure
- Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination or x-ray
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 RetractorTongue implant | Device | LTR Treatment |
Primary outcome
Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing
Time frame: 1 year
Recording of Apnea Hypopnea Index through polysomnography during overnight sleep study
2 secondary outcomes
Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device
Time frame: 1 year
Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Balwinder Singh, MD principal investigator
Putrajaya Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Linguaflex Tongue Retractor in people with Obstructive Sleep Apnea, run by Linguaflex, Inc..
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing (time frame: 1 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 Aug 2018.