NCT01211444

Brief Summary

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 15, 2015

Status Verified

October 1, 2011

Enrollment Period

3.1 years

First QC Date

August 20, 2010

Last Update Submit

April 14, 2015

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaOSAHypoglossal nerve stimulationSleep apnea

Outcome Measures

Primary Outcomes (5)

  • Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline

    6 months post-implant

  • Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline

    6 months post-implant

  • The frequency of serious adverse events.

    One month post-implant.

  • The frequency of serious adverse events.

    3 months post-implant.

  • The frequency of serious adverse events.

    6 months post-implant.

Study Arms (1)

HGNS System

EXPERIMENTAL
Device: HGNS Treatment

Interventions

HGNS TreatmentDEVICE

The Apnex Hypoglossal Nerve Stimulation System (HGNS) is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping and off when the patient is awake.

HGNS System

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eligibility Criteria 1. Previously diagnosed with moderate-to-severe obstructive sleep apnea. 2. Subject has failed or does not tolerate CPAP treatment. 3. Age between 21 and 70 years. 4. Body mass index (BMI) less than or equal to 37.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Saint Vincent Hospital

Indianapolis, Indiana, 46260, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Clinilabs, Inc.

New York, New York, 10019, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jon Freeman, PhD

    Clinilabs, Inc. West Side ENT, NY, NY

    PRINCIPAL INVESTIGATOR

  • Tod Huntley, MD

    Center for Ear, Nose, Throat and Allegery, PC (Centa), Carmel, IN

    PRINCIPAL INVESTIGATOR

  • Con Iber, MD

    Dept of Neurology, University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Eric Kezirian, MD

    University of Califoprnia - San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2010

First Posted

September 29, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 15, 2015

Record last verified: 2011-10

Locations

US(4)