NCT03066765

Brief Summary

Study of tongue implant for treatment of obstructive sleep apnea

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

February 23, 2017

Last Update Submit

August 8, 2018

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (2)

  • Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device

    1 year

  • Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale

    1 year

Study Arms (1)

LTR Treatment

EXPERIMENTAL

An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy

Device: Linguaflex Tongue Retractor

Interventions

Linguaflex Tongue RetractorDEVICE

Tongue implant

LTR Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHI\>10
  • years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Balwinder Singh, MD

    Putrajaya Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2017

First Posted

February 28, 2017

Study Start

February 25, 2016

Primary Completion

November 21, 2017

Study Completion

February 5, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share