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NCT01446601 · ClinicalTrials.gov registry record · Phase 3
Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
A Phase 3 study, sponsored by Apnex Medical.
- Terminated
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
NCT01446601: Clinical Trial Phase 3 study, sponsored by Apnex Medical.
NCT01446601 is a Phase 3 study that was terminated before completion, run by Apnex Medical. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01446601, a Phase 3 study, was terminated before completion, sponsored by Apnex Medical.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.
Primary Outcome
The proportion of subjects that experience clinically meaningful improvement in AH1 (reduction \>50% and AHI \<20) and ODI 4% (reduction \>= 25% or ODI 4% \<5)from Baseline to 6 Months will be significantly greater in the Treatment Group compared to the Control Group
Interventions
- DEVICE Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
Why NCT01446601 stopped before completion
NCT01446601 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) is the first listed.
NCT01446601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01446601 about?
NCT01446601 is a clinical study titled "Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea". The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not toler...
What is the current status of trial NCT01446601?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2011-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01446601?
The interventions under investigation include: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) (DEVICE).
Who is sponsoring clinical trial NCT01446601?
This trial is sponsored by Apnex Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01446601's enrollment target sits among peer trials
132 1588th of 2000 higher than 408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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