Back to resultsLTR for Treatment of Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Linguaflex Tongue Retractor
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- AHI>10
- 18 years of age
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LTR Treatment
Arm Description
An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03066765
Brief Title
LTR for Treatment of Obstructive Sleep Apnea
Official Title
Non-Randomized, Single Arm Study of the New Linguaflex Tongue Retractor for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 25, 2016 (Actual)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
February 5, 2018 (Actual)
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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LTR Treatment
Arm Type
Experimental
Arm Description
An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy
Intervention Type
Device
Intervention Name(s)
Linguaflex Tongue Retractor
Intervention Description
Tongue implant
Primary Outcome Measure Information:
Title
Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing
Description
Recording of Apnea Hypopnea Index through polysomnography during overnight sleep study
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device
Description
Assessment of Adverse Events and Serious Adverse Events
Time Frame
1 year
Title
Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale
Description
Assess level of sleepiness pre and post treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
AHI>10
18 years of age
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balwinder Singh, MD
Organizational Affiliation
Putrajaya Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
LTR for Treatment of Obstructive Sleep Apnea
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