LTR for Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Non-Randomized, Single Arm Study of the New Linguaflex Tongue Retractor for the Treatment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066765
• Other study ID #: LTR-005-V01.2
• Status: Completed
• Phase: N/A
• Start date: February 25, 2016
• Est. completion date: February 5, 2018

Study information

• Verified date: August 2018
• Source: Linguaflex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of tongue implant for treatment of obstructive sleep apnea

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 5, 2018
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Linguaflex Tongue Retractor
Tongue implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Linguaflex, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 year
Secondary	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	1 year