Obstructive Sleep ApneaPhase 2/3NCT01186926
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
A Phase 2/3 study testing HGNS Treatment in people with Obstructive Sleep Apnea, run by Apnex Medical, Inc..
Trial summary
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- HGNS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to May 2013
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligibility Criteria
- Previously diagnosed with moderate to severe obstructive sleep apnea.
- Subject has failed or does not tolerate CPAP treatment.
- Age between 21 and 70 years.
- Body mass index (BMI) less than or equal to 40
About this study
Official title: Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- HGNS Treatment
- Keywords
- Obstructive sleep apnea, OSA, hypoglossal nerve stimulation, sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGNS TreatmentDevice
The Apnex Hypoglossal Nerve Stimulation (HGNS) System 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.
| Study group | Role | What they receive |
|---|---|---|
| HGNS Treatment | Experimental | Not described Receives: Device: HGNS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Measured: 6 months post-implant
Adverse event profile interoperatively, perioperatively, and long term post implant
Measured: 1, 3, 6, 12, 24, and 36 months post implant
Secondary outcomes (1)
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline
Measured: 6 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apnex Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maree Barnes, MD, Principal investigator, Institute for Breathing and Sleep, Austin HealthDavid Hillman, MD, Principal investigator, West Australian Sleep Disorders Research Institute, St. Charles Gardner HospitalDoug McEvoy, MD, Principal investigator, Adelaide Institute for Sleep Health, Repatriation General HospitalJohn Wheatley, MD, Principal investigator, Westmead Hospital Dept of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186926
- Sponsor's protocol ID
- CLP-003
- Status last verified
- Dec 2011
- First submitted
- 20 Aug 2010
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011 Nov 1;34(11):1479-86. doi: 10.5665/sleep.1380.
PubMed 22043118
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
- Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01186926
- Acronym / sponsor ID
- CLP-003
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, OSA, hypoglossal nerve stimulation, sleep apnea
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Apnex Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Aug 2010 (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 overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HGNS Treatment | Experimental | Device: HGNS Treatment |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HGNS TreatmentThe Apnex Hypoglossal Nerve Stimulation (HGNS) System 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. | Device | HGNS Treatment |
Primary outcome
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Time frame: 6 months post-implant
Adverse event profile interoperatively, perioperatively, and long term post implant
Time frame: 1, 3, 6, 12, 24, and 36 months post implant
1 secondary outcome
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline
Time frame: 6 months post-implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Results publication: PubMed 22043118Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011 Nov 1;34(11):1479-86. doi: 10.5665/sleep.1380.
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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.
Maree Barnes, MD principal investigator
Institute for Breathing and Sleep, Austin Health
David Hillman, MD principal investigator
West Australian Sleep Disorders Research Institute, St. Charles Gardner Hospital
Doug McEvoy, MD principal investigator
Adelaide Institute for Sleep Health, Repatriation General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HGNS Treatment in people with Obstructive Sleep Apnea, run by Apnex Medical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, 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.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline (time frame: 6 months post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186926, which also lists 1 linked publication.
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.