Obstructive Sleep ApneaPhase 3NCT01446601
Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
A Phase 3 study testing Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) in people with Obstructive Sleep Apnea, run by Apnex Medical, Inc. at 14 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Aug 2011to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 80 years
- Body mass index (BMI) ≤ 35 kg/m²
- Previously diagnosed with Moderate to severe OSA
- Individual has failed or does not tolerate PAP therapy
Who cannot join
None listed.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Community Research
Cincinnati, Ohio, 45230
Sleep Med of South Carolina
Columbia, South Carolina, 29201
Henry Ford Hospital
Detroit, Michigan, 48202
MidAmerica Neuroscience Research Institute
Lenexa, Kansas, 66214
Kentucky Research Group
Louisville, Kentucky, 40217
University of Minnesota
Minneapolis, Minnesota, 55454
Clinilabs
New York, New York, 10019
Sleep Therapy and Research Center
San Antonio, Texas, 78229
St. Lukes Hospital
St Louis, Missouri, 63017
Veritas Clinical Specialties
Topeka, Kansas, 66606
Wilmington Medical Research
Wilmington, North Carolina, 28401
Australia2 sites
IBAS, The Austin Hospital
Melbourne, Victoria, 3084
Westmead Hospital
Sydney, New South Wales, 2145
About this study
Official title: Pivotal Study of the Apnex Medical™ 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 tolerate positive airway pressure (PAP) therapy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
- Keywords
- Apnea, OSA, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypoglossal Nerve Stimulation, Sleep Disorders, Tongue
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea, Sleep Apnea Syndromes, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )Device
The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant. Receives: Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) |
| Control | Other | The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant. Receives: Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in OSA Severity
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
Measured: from Baseline to 6 Months
Long-term Reduction in OSA Severity
The proportion of subjects in the Treatment Group that experience clinically relevant improvement in AHI (reduction >50% and AHI <20) and ODI 4% (reduction >=25% or ODI 4% <5 at 12 months compared to Baseline.
Measured: 12 months
Safety Analysis
Description of all adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apnex Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446601
- Sponsor's protocol ID
- CLP-005
- Other IDs
- IDE #G090014
- Status last verified
- Dec 2011
- First submitted
- 2 Sep 2011
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01446601
- Acronym / sponsor ID
- CLP-005
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Apnea, OSA, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypoglossal Nerve Stimulation, Sleep Disorders, Tongue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Apnex Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant. |
| Control | Other | Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 to 80 years
- Body mass index (BMI) ≤ 35 kg/m²
- Previously diagnosed with Moderate to severe OSA
- Individual has failed or does not tolerate PAP therapy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy. | Device | Control, Treatment |
Primary outcome
Reduction in OSA Severity
Time frame: from Baseline to 6 Months
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
Long-term Reduction in OSA Severity
Time frame: 12 months
The proportion of subjects in the Treatment Group that experience clinically relevant improvement in AHI (reduction >50% and AHI <20) and ODI 4% (reduction >=25% or ODI 4% <5 at 12 months compared to Baseline.
Safety Analysis
Time frame: 12 months
Description of all adverse events
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) in people with Obstructive Sleep Apnea, run by Apnex Medical, Inc. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in OSA Severity (time frame: from Baseline to 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.