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Clinical Trials/NCT01211444
NCT01211444CompletedPhase 2

US Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

Apnex Medical, Inc.7 sites in 1 country20 target enrollmentStarted: July 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
20
Locations
7
Primary Endpoint
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 6 months post-implant

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

Time Frame: 6 months post-implant

The frequency of serious adverse events.

Time Frame: 6 months post-implant.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (7)

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US Clinical Study of the Apnex Medical... | Clinical Trial