Sleep Apnea SyndromesNCT01532180
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
A study testing aura6000 System in people with Sleep Apnea Syndromes and Sleep Apnea, Obstructive, run by ImThera Medical, Inc. at 1 site in Belgium.
Trial summary
The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA). Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders
- What is being tested?
- aura6000 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2009to Dec 2011
- Phase
- Interventional
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe obstructive sleep apnea (AHI 15 to 60).
- Cannot or will not tolerate CPAP treatment.
- Body mass index (BMI) between 25 and 40
- Able to read, understand, sign and date the written informed consent form
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea
The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Syndrome, Obstructive Sleep Apnea
- Being tested
- aura6000 System
- Keywords
- Obstructive sleep apnea, neurostimulation, hypoglossal nerve
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aura6000 SystemDevice
The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.
| Study group | Role | What they receive |
|---|---|---|
| THN Therapy | Experimental | Not described Receives: Device: aura6000 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
Measured: 3 and 12 months post-implant
Adverse events and Serious Adverse events peri and post-operatively
Measured: 3 and 12 months post-operative
Secondary outcomes (2)
Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.
Measured: 3 and 12 months post-operative
Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.
Measured: 3 and 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startNov 2009
- Primary completionDec 2011
- Study completionDec 2011
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 Sleep Apnea SyndromesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImThera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Rodenstein, MD, Principal investigator, Clinique Univ. Saint-Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532180
- Sponsor's protocol ID
- IMT 2009-01/02/03
- Status last verified
- Aug 2019
- First submitted
- 9 Feb 2012
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17.
PubMed 22599356
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01532180
- Acronym / sponsor ID
- IMT 2009-01/02/03
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Syndrome, Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, neurostimulation, hypoglossal nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ImThera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Feb 2012 (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 objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of 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 |
|---|---|---|
| THN Therapy | Experimental | Device: aura6000 System |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe obstructive sleep apnea (AHI 15 to 60).
- Cannot or will not tolerate CPAP treatment.
- Body mass index (BMI) between 25 and 40
- Able to read, understand, sign and date the written informed consent form
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 |
|---|---|---|
| aura6000 SystemThe aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep. | Device | THN Therapy |
Primary outcome
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
Time frame: 3 and 12 months post-implant
Adverse events and Serious Adverse events peri and post-operatively
Time frame: 3 and 12 months post-operative
2 secondary outcomes
Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.
Time frame: 3 and 12 months post-operative
Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.
Time frame: 3 and 12 months post-implantation
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 12 Aug 2019.
- Derived from this study: PubMed 22599356Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17.
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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.
Daniel Rodenstein, MD principal investigator
Clinique Univ. Saint-Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aura6000 System in people with Sleep Apnea Syndromes and Sleep Apnea, Obstructive, run by ImThera Medical, Inc. at 1 site in Belgium.
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: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
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 through in-lab polysomnography (PSG) compared to baseline. (time frame: 3 and 12 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 NCT01532180, 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 12 Aug 2019.