Sleep Apnea SyndromesTHN2NCT01796925
Targeted Hypoglossal Neurostimulation Study #2
A study testing aura6000 THN System in people with Sleep Apnea Syndromes and Sleep Apnea, Obstructive, run by ImThera Medical, Inc. at 9 sites in 5 countries.
Trial summary
The objective of the study is to confirm the safety and 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 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders
- What is being tested?
- aura6000 THN System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Feb 2013to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI >20
- Noncompliant to CPAP
- Willing to provide informed consent
- Willing to comply with all follow-up visits and evaluations
Who cannot join
- BMI limits
- COPD
- Central Sleep Apnea
- Anatomic variations interfering with device placement or stability.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
United States4 sites
Chicago ENT
Chicago, Illinois, 60657
Porter Adventist Hospital
Denver, Colorado, 80210
Orange Regional Medical Center
Middletown, New York, 10940
Sharp Rees Stealy Medical Center
San Diego, California, 92123
Germany2 sites
Advanced Sleep Research
Berlin, 10117
St. Joseph-Stift
Bremen, 28209
About this study
Official title: Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System
The objective of the study is to confirm the safety and 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 THN System
- Keywords
- Apnea, Respiration Disorders, Signs and Symptoms, Signs and Symptoms, Respiratory, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Sleep Disorders, Nervous System Diseases
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Apnea, Signs and Symptoms, Respiratory Tract Diseases, Sleep Disorders, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aura6000 THN 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 |
|---|---|---|
| aura6000 THN Therapy | Experimental | The aura6000 THN system will be implanted and activated for nightly therapy during sleep. Receives: Device: aura6000 THN System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Apnea-Hypopnea Index (AHI)
Change from baseline in AHI measured through in-lab polysomnography (PSG).
Measured: 3, 6, and 12 months post implant
Reduction in Oxygen Desaturation Index (ODI)
Change from baseline in ODI measured through in-lab polysomnography (PSG).
Measured: 3, 6, and 12 months post implant
Freedom from Serious Adverse Events (SAE)
Adverse events and Serious Adverse events post-operatively
Measured: 1 and 12 months post implant
Secondary outcomes (3)
Improvement in sleep fragmentation
Mean change in microarousal index as compared to baseline.
Measured: 3, 6, and 12 months post-implant
Improvement in SAQLI
Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.
Measured: 3, 6, and 12 months post implant
Improvement in ESS
Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.
Measured: 3, 6, and 12 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 posted22 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImThera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Rodenstein, MD, PhD, Principal investigator, Clinique Univ. Saint-LucOfer Jacobowitz, MD PhD, Principal investigator, Hudson Valley ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796925
- Sponsor's protocol ID
- IMT2012-02
- Acronym
- THN2
- Status last verified
- Aug 2019
- First submitted
- 14 Feb 2013
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation. 2013 Jul-Aug;16(4):376-86; discussion 386. doi: 10.1111/j.1525-1403.2012.00514.x. Epub 2012 Aug 31.
PubMed 22938390Mwenge 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
- Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System
- ClinicalTrials.gov ID
- NCT01796925
- Acronym / sponsor ID
- THN2 / IMT2012-02
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Syndrome, Obstructive Sleep Apnea
- Keywords
- Apnea, Respiration Disorders, Signs and Symptoms, Signs and Symptoms, Respiratory, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Tract Diseases, Sleep Disorders, Intrinsic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- ImThera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Feb 2013 (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 confirm the safety and 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 |
|---|---|---|
| aura6000 THN Therapy | Experimental | Device: aura6000 THN SystemThe aura6000 THN system will be implanted and activated for nightly therapy during sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AHI >20
- Noncompliant to CPAP
- Willing to provide informed consent
- Willing to comply with all follow-up visits and evaluations
Key exclusion criteria (4 listed)
- BMI limits
- COPD
- Central Sleep Apnea
- Anatomic variations interfering with device placement or stability.
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 THN 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 | aura6000 THN Therapy |
Primary outcome
Reduction in Apnea-Hypopnea Index (AHI)
Time frame: 3, 6, and 12 months post implant
Change from baseline in AHI measured through in-lab polysomnography (PSG).
Reduction in Oxygen Desaturation Index (ODI)
Time frame: 3, 6, and 12 months post implant
Change from baseline in ODI measured through in-lab polysomnography (PSG).
Freedom from Serious Adverse Events (SAE)
Time frame: 1 and 12 months post implant
Adverse events and Serious Adverse events post-operatively
3 secondary outcomes
Improvement in sleep fragmentation
Time frame: 3, 6, and 12 months post-implant
Improvement in SAQLI
Time frame: 3, 6, and 12 months post implant
Improvement in ESS
Time frame: 3, 6, and 12 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 12 Aug 2019.
- Background: PubMed 22938390Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation. 2013 Jul-Aug;16(4):376-86; discussion 386. doi: 10.1111/j.1525-1403.2012.00514.x. Epub 2012 Aug 31.
- Background: 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, PhD principal investigator
Clinique Univ. Saint-Luc
Ofer Jacobowitz, MD PhD principal investigator
Hudson Valley ENT
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aura6000 THN System in people with Sleep Apnea Syndromes and Sleep Apnea, Obstructive, run by ImThera Medical, Inc. at 9 sites in 5 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 4 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 9 sites in United States, Germany, Belgium, France, Italy. 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?
Reduction in Apnea-Hypopnea Index (AHI) (time frame: 3, 6, and 12 months post implant). 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?
On the ClinicalTrials.gov record for NCT01796925, which also lists 2 linked publications.
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.