Sleep Apnea, ObstructiveNCT00490984
Tongue Advancement for Obstructive Sleep Apnea
A study testing Aspire Medical Advance System in people with Sleep Apnea, Obstructive, run by Aspire Medical at 3 sites in 3 countries.
Trial summary
The objective of this study is to assess the feasibility, safety and effectiveness of tongue stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Aspire Medical Advance System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2006to Jul 2009
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of obstructive sleep apnea with AHI 15-50 measured within a year prior to enrollment with no major change in BMI
- Bewteen 20 and 65 years old
- Body Mass Index (BMI) ≤ 32
- Patient has been offered CPAP and has refused or failed to continue CPAP treatment
- Identified evidence of airway collapse, primarily at the base of the tongue
- Signed informed consent to participate in this clinical study
Who cannot join
- Prior OSA surgery except tonsillectomy, nasal surgery and uvulopalatopharyngoplasty; no airway surgery within 3 months prior to enrollment.
- Airway collapse at the level of the soft palate (palatal collapse).
- Enlarged tonsils (3+ and 4+)
- Anatomy unable to accommodate the implant
- Severe mandibular deficiency/retrognathia
- Unable and/or not willing to comply with treatment follow-up requirements.
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- Pregnancy. (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study)
- Breastfeeding women
- Active systemic infection
- Allergy to any medication used during implantation
- Previous history of neck or upper respiratory tract cancer
- History of radiation therapy to neck or upper respiratory tract
- Dysphagia
- Major cardiovascular and pulmonary disorders
- Other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment
- Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Tongue Advancement for Obstructive Sleep Apnea. An Evaluation fo the Aspire Medical Advance System.
The objective of this study is to assess the feasibility, safety and effectiveness of tongue stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by polysomnography (PSG) from baseline to 6 months.
Read the detailed description
Obstructive sleep apnea (OSA) is a major health problem in the United States and can result in excessive daytime sleepiness and cardiovascular problems. The primary treatment for OSA today is continuous positive airway pressure (CPAP). Many patients however are unable to tolerate sleeping with a CPAP machine. Surgery is one of the main treatment options available today to these CPAP-intolerant patients. However, current methods of sleep surgery are painful, morbid, and/or lack decent effectiveness.
This trial will measure the effectiveness of the Advance System, an implantable medical device to treat OSA. In the trial, patients who meet the study entry criteria receive a baseline sleep study (PSG). The Advance System is then implanted and 6 months after implantation, another PSG is performed. The trial will compare the baseline and the 6 month apnea-hypopnea indices
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Aspire Medical Advance System
- Keywords
- obstructive sleep apena, tongue, surgery
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspire Medical Advance SystemDevice
The treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep.
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the feasibility of tongue stabilization using the Advance™ System. Product implantation and stabilization of the tongue using the Advance™system will be measured by Pharyngoscopy and Cephalogram
Measured: 3 months
Evaluate the safety of the Advance™ System 3 Months after implantation.
Measured: 3 months
Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies.
Measured: 6 months
Secondary outcomes (2)
Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation
Measured: 3 months
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startFeb 2006
- Primary completionFeb 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boris A. Stuck, MD, Principal investigator, Deparment of Otorhinolaryngology, Head and Neck Surgery, University Hospital MannheimEvert Hamans, MD, Principal investigator, Department of Otorhinolaryngology, University Hospital Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490984
- Sponsor's protocol ID
- TAS 001
- Status last verified
- Apr 2009
- First submitted
- 21 Jun 2007
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Advancement for Obstructive Sleep Apnea. An Evaluation fo the Aspire Medical Advance System.
- ClinicalTrials.gov ID
- NCT00490984
- Acronym / sponsor ID
- TAS 001
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- obstructive sleep apena, tongue, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aspire MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Jun 2007 (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 this study is to assess the feasibility, safety and effectiveness of tongue stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by polysomnography (PSG) from baseline to 6 months.
Detailed description
Obstructive sleep apnea (OSA) is a major health problem in the United States and can result in excessive daytime sleepiness and cardiovascular problems. The primary treatment for OSA today is continuous positive airway pressure (CPAP). Many patients however are unable to tolerate sleeping with a CPAP machine. Surgery is one of the main treatment options available today to these CPAP-intolerant patients. However, current methods of sleep surgery are painful, morbid, and/or lack decent effectiveness.
This trial will measure the effectiveness of the Advance System, an implantable medical device to treat OSA. In the trial, patients who meet the study entry criteria receive a baseline sleep study (PSG). The Advance System is then implanted and 6 months after implantation, another PSG is performed. The trial will compare the baseline and the 6 month apnea-hypopnea indices
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented diagnosis of obstructive sleep apnea with AHI 15-50 measured within a year prior to enrollment with no major change in BMI
- Bewteen 20 and 65 years old
- Body Mass Index (BMI) ≤ 32
- Patient has been offered CPAP and has refused or failed to continue CPAP treatment
- Identified evidence of airway collapse, primarily at the base of the tongue
Key exclusion criteria (16 listed)
- Prior OSA surgery except tonsillectomy, nasal surgery and uvulopalatopharyngoplasty; no airway surgery within 3 months prior to enrollment.
- Airway collapse at the level of the soft palate (palatal collapse).
- Enlarged tonsils (3+ and 4+)
- Anatomy unable to accommodate the implant
- Severe mandibular deficiency/retrognathia
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 |
|---|---|---|
| Aspire Medical Advance SystemThe treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep. | Device | – |
Primary outcome
Demonstrate the feasibility of tongue stabilization using the Advance™ System. Product implantation and stabilization of the tongue using the Advance™system will be measured by Pharyngoscopy and Cephalogram
Time frame: 3 months
Evaluate the safety of the Advance™ System 3 Months after implantation.
Time frame: 3 months
Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies.
Time frame: 6 months
2 secondary outcomes
Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation
Time frame: 3 months
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation
Time frame: 3 months
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 23 Dec 2009.
- Sponsor's web site; has basic product \& patient informationLink provided by the sponsor.
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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.
Boris A. Stuck, MD principal investigator
Deparment of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim
Evert Hamans, MD principal investigator
Department of Otorhinolaryngology, University Hospital Antwerp
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspire Medical Advance System in people with Sleep Apnea, Obstructive, run by Aspire Medical at 3 sites in 3 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 6 inclusion and 16 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 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Czechia, Germany. 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?
Demonstrate the feasibility of tongue stabilization using the Advance™ System. Product implantation and stabilization of the tongue using the Advance™system will be measured by Pharyngoscopy and Cephalogram (time frame: 3 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 23 Dec 2009.