Targeted Hypoglossal Neurostimulation Study #2

Sleep Apnea, Obstructive Clinical Trial

— THN2  

Official title:

Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796925
• Other study ID #: IMT2012-02
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2019
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AHI >20

• Noncompliant to CPAP

• Willing to provide informed consent

• Willing to comply with all follow-up visits and evaluations

Exclusion Criteria:

• BMI limits

• COPD

• Central Sleep Apnea

• Anatomic variations interfering with device placement or stability.

Related Conditions & MeSH terms

• Apnea
• Respiration Disorders
• Signs and Symptoms
• Signs and Symptoms, Respiratory
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome
• Syndrome, Obstructive Sleep Apnea

Intervention

Device:
• aura6000 THN System
The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.

Locations

Country	Name	City	State
Belgium	Clinique Univ. Saint-Luc	Brussels
France	Pitié-Salpêtrière Hospital	Paris
Germany	Advanced Sleep Research	Berlin
Germany	St. Joseph-Stift	Bremen
Italy	G.B. Morgagni- L. Pierantoni Hospital	Forli
United States	Chicago ENT	Chicago	Illinois
United States	Porter Adventist Hospital	Denver	Colorado
United States	Orange Regional Medical Center	Middletown	New York
United States	Sharp Rees Stealy Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
ImThera Medical, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy, 

References & Publications (2)

Mwenge GB, Rombaux P, Dury M, Lengelé B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17. — View Citation

Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation. 2013 Jul-Aug;16(4):376-86; discussion 386. doi: 10.1111/j.1525-1403.2012.00514.x. Epub 2012 Aug 31. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Apnea-Hypopnea Index (AHI)	Change from baseline in AHI measured through in-lab polysomnography (PSG).	3, 6, and 12 months post implant
Primary	Reduction in Oxygen Desaturation Index (ODI)	Change from baseline in ODI measured through in-lab polysomnography (PSG).	3, 6, and 12 months post implant
Primary	Freedom from Serious Adverse Events (SAE)	Adverse events and Serious Adverse events post-operatively	1 and 12 months post implant
Secondary	Improvement in sleep fragmentation	Mean change in microarousal index as compared to baseline.	3, 6, and 12 months post-implant
Secondary	Improvement in SAQLI	Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.	3, 6, and 12 months post implant
Secondary	Improvement in ESS	Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.	3, 6, and 12 months post implant