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Targeted Hypoglossal Neurostimulation Study #2 (THN2)

Primary Purpose

Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
aura6000 THN System
Sponsored by
ImThera Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Apnea, Respiration Disorders, Signs and Symptoms, Signs and Symptoms, Respiratory, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Sleep Disorders, Nervous System Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sharp Rees Stealy Medical Center
  • Porter Adventist Hospital
  • Chicago ENT
  • Orange Regional Medical Center
  • Clinique Univ. Saint-Luc
  • Pitié-Salpêtrière Hospital
  • Advanced Sleep Research
  • St. Joseph-Stift
  • G.B. Morgagni- L. Pierantoni Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aura6000 THN Therapy

Arm Description

The aura6000 THN system will be implanted and activated for nightly therapy during sleep.

Outcomes

Primary Outcome Measures

Reduction in Apnea-Hypopnea Index (AHI)
Change from baseline in AHI measured through in-lab polysomnography (PSG).
Reduction in Oxygen Desaturation Index (ODI)
Change from baseline in ODI measured through in-lab polysomnography (PSG).
Freedom from Serious Adverse Events (SAE)
Adverse events and Serious Adverse events post-operatively

Secondary Outcome Measures

Improvement in sleep fragmentation
Mean change in microarousal index as compared to baseline.
Improvement in SAQLI
Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.
Improvement in ESS
Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.

Full Information

First Posted
February 14, 2013
Last Updated
August 8, 2019
Sponsor
ImThera Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01796925
Brief Title
Targeted Hypoglossal Neurostimulation Study #2
Acronym
THN2
Official Title
Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImThera Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Syndrome, Obstructive Sleep Apnea
Keywords
Apnea, Respiration Disorders, Signs and Symptoms, Signs and Symptoms, Respiratory, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Sleep Disorders, Nervous System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aura6000 THN Therapy
Arm Type
Experimental
Arm Description
The aura6000 THN system will be implanted and activated for nightly therapy during sleep.
Intervention Type
Device
Intervention Name(s)
aura6000 THN System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Apnea-Hypopnea Index (AHI)
Description
Change from baseline in AHI measured through in-lab polysomnography (PSG).
Time Frame
3, 6, and 12 months post implant
Title
Reduction in Oxygen Desaturation Index (ODI)
Description
Change from baseline in ODI measured through in-lab polysomnography (PSG).
Time Frame
3, 6, and 12 months post implant
Title
Freedom from Serious Adverse Events (SAE)
Description
Adverse events and Serious Adverse events post-operatively
Time Frame
1 and 12 months post implant
Secondary Outcome Measure Information:
Title
Improvement in sleep fragmentation
Description
Mean change in microarousal index as compared to baseline.
Time Frame
3, 6, and 12 months post-implant
Title
Improvement in SAQLI
Description
Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.
Time Frame
3, 6, and 12 months post implant
Title
Improvement in ESS
Description
Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.
Time Frame
3, 6, and 12 months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rodenstein, MD, PhD
Organizational Affiliation
Clinique Univ. Saint-Luc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ofer Jacobowitz, MD PhD
Organizational Affiliation
Hudson Valley ENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Rees Stealy Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Chicago ENT
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Orange Regional Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940
Country
United States
Facility Name
Clinique Univ. Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Pitié-Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Advanced Sleep Research
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
St. Joseph-Stift
City
Bremen
ZIP/Postal Code
28209
Country
Germany
Facility Name
G.B. Morgagni- L. Pierantoni Hospital
City
Forli
ZIP/Postal Code
47121
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22938390
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.
Results Reference
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PubMed Identifier
22599356
Citation
Mwenge GB, Rombaux P, Dury M, Lengele 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.
Results Reference
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Targeted Hypoglossal Neurostimulation Study #2

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