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Completed

NCT Number: NCT01796925

Targeted Hypoglossal Neurostimulation Study #2

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).

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Syndrome, Obstructive Sleep Apnea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Univ. Saint-Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aura6000 THN System

Device

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 outcomes

  1. Reduction in Apnea-Hypopnea Index (AHI)

    Time frame: 3, 6, and 12 months post implant

    Change from baseline in AHI measured through in-lab polysomnography (PSG).

  2. Reduction in Oxygen Desaturation Index (ODI)

    Time frame: 3, 6, and 12 months post implant

    Change from baseline in ODI measured through in-lab polysomnography (PSG).

  3. Freedom from Serious Adverse Events (SAE)

    Time frame: 1 and 12 months post implant

    Adverse events and Serious Adverse events post-operatively

Secondary outcomes

  1. Improvement in sleep fragmentation

    Time frame: 3, 6, and 12 months post-implant

    Mean change in microarousal index as compared to baseline.

  2. Improvement in SAQLI

    Time frame: 3, 6, and 12 months post implant

    Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.

  3. Improvement in ESS

    Time frame: 3, 6, and 12 months post implant

    Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.

Sponsors and collaborators

Lead sponsor

ImThera Medical, Inc.

Industry

Registry information

Official study title

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

Acronym: THN2

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 22, 2013
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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