Sleep Apnea, ObstructiveNCT00467324
The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
A study testing Aspire Medical Advance System in people with Sleep Apnea, Obstructive, run by Aspire Medical at 4 sites in United States.
Trial summary
The objective of the study is to assess the effectiveness of the Aspire Medical Advance System in obstructive sleep apnea by demonstrating a statistically significant mean reduction in the apnea-hypopnea index (AHI) from baseline to 6 months, measured by polysomnography (PSG). Read more about this study
- Who is it for?
- Ages 18 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
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2007to Dec 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously diagnosed or screened with moderate to severe sleep apnea who have an AHI of between 15 and 60
- Age between 18 and 65
- Body mass index (BMI) </= 32
- Patient has been offered CPAP and has refused or failed to continue CPAP treatment
- Identified evidence of airway collapse at the base of the tongue
- Signed informed consent
Who cannot join
- Prior OSA surgery except tonsillectomy, adenoidectomy, and nasal surgery
- Enlarged tonsils (3+ and 4+)
- Anatomy unable to accommodate the implant
- Severe mandibular deficiency/retrognathia
- Significant rhinitis/nasal obstruction
- Unable and/or not willing to comply with treatment follow-up requirements
Show all 19Show fewer
- Pregnancy (female subjects of childbearing age mus have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study) or breastfeeding
- Active systemic infection
- Allergy to latex or 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
- History of major cardiovascular disorders including MI, angina, uncontrolled hypertension, and CHF
- Major pulmonary disorders including COPD and uncontrolled asthma
- Patient is suffering from untreated/inadequately treated major depression, as determined by history
- History of falling asleep driving or motor vehicle accident secondary to excessive sleepiness
- Anesthesia risk group ASA Class IV or V
- Other medical, social or psychological problems that, in the opinion of the investigator, could complicate the procedure and/or recovery from this treatment or could complicate the procedures and evaluations pre- and post-treatment
- Enrollment in another pharmacological or medical device study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northside Hospital/Advanced Ear Nose & Throat Associates PC
Atlanta, Georgia, 30342
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
St. Vincent's Hospital
Indianapolis, Indiana, 46032
Medical College of Wisconsin
Milwaukee, Wisconsin, 53051
About this study
The objective of the study is to assess the effectiveness of the Aspire Medical Advance System in obstructive sleep apnea by demonstrating a statistically significant mean reduction in the apnea-hypopnea index (AHI) from baseline to 6 months, measured by polysomnography (PSG).
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 apnea, surgery, tongue
- 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.
Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System
Measured: 6 months
Secondary outcomes (3)
Epworth Sleepiness Scale (ESS) measured at 6 months post-implantation
Measured: 6 months
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 6 months post-implantation
Measured: 6 months
Safety: assessment of all device-related and procedure related adverse events and their seriousness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionDec 2008 (estimated)
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tucker Woodson, MD, Principal investigator, Department of OTO-HNS Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467324
- Sponsor's protocol ID
- TAS 002
- Status last verified
- Oct 2008
- First submitted
- 26 Apr 2007
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
- ClinicalTrials.gov ID
- NCT00467324
- Acronym / sponsor ID
- TAS 002
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- obstructive sleep apnea, surgery, tongue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aspire MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 30 Apr 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 the study is to assess the effectiveness of the Aspire Medical Advance System in obstructive sleep apnea by demonstrating a statistically significant mean reduction in the apnea-hypopnea index (AHI) from baseline to 6 months, measured by polysomnography (PSG).
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
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previously diagnosed or screened with moderate to severe sleep apnea who have an AHI of between 15 and 60
- Age between 18 and 65
- Body mass index (BMI) </= 32
- Patient has been offered CPAP and has refused or failed to continue CPAP treatment
- Identified evidence of airway collapse at the base of the tongue
Key exclusion criteria (19 listed)
- Prior OSA surgery except tonsillectomy, adenoidectomy, and nasal surgery
- Enlarged tonsils (3+ and 4+)
- Anatomy unable to accommodate the implant
- Severe mandibular deficiency/retrognathia
- Significant rhinitis/nasal obstruction
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
Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System
Time frame: 6 months
3 secondary outcomes
Epworth Sleepiness Scale (ESS) measured at 6 months post-implantation
Time frame: 6 months
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 6 months post-implantation
Time frame: 6 months
Safety: assessment of all device-related and procedure related adverse events and their seriousness
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
- 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.
Tucker Woodson, MD principal investigator
Department of OTO-HNS Medical College of Wisconsin
4 sites in 1 country: 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 4 sites in United States.
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 19 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: status not confirmed, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
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?
Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System (time frame: 6 months). 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 Oct 2008.