Obstructive Sleep ApneaPhase 4NCT00307957
Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
A Phase 4 study testing Pillar Palatal Implants in people with Obstructive Sleep Apnea, run by University of Cincinnati at 3 sites in United States.
Trial summary
The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Pillar Palatal Implants
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2005to Oct 2006
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Body Mass Index equal to 32 or less
- Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30
- Symptoms of daytime sleepiness
Who cannot join
- Septal deviation or nasal obstruction
- Nasal polyps
- Severe seasonal allergies
- Soft palate length insufficient to accommodate implants
- Fujita Modified Mallampati Class 3
- Large tonsils
Show all 18Show fewer
- Lingual tonsil hypertrophy
- Hypopharyngeal obstruction
- Previous pharyngeal surgery
- Previous upper respiratory tract cancer or radiation therapy
- Active respiratory tract infection
- Dysphagia or speech disorder
- Neurologic disorder
- Unstable psychiatric disorder
- Pregnant or breastfeeding
- History of falling asleep driving or MVA due to sleepiness
- Currently on CPAP therapy or other device for OSA
- Other sleep disorders
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Ear, Nose and Throat Specialists
Cincinnati, Ohio, 45267-0528
University of Indiana Medical Center
Indianapolis, Indiana
Department of OTO-HNS Medical College of Wisconsin
Milwaukee, Wisconsin, 53022
About this study
Official title: Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea
The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.
Read the detailed description
Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant group or a placebo/sham group.
In both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. Patients will also undergo reaction time testing on hand-held device similar to a pocket video game. At the three month visit, patients will return to the sleep lab for another sleep study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Pillar Palatal Implants
- Keywords
- Obstructive Sleep Apnea, Daytime Sleepiness, Pillar Palatal Implants
- Medical subject headings
- Sleep Apnea, Obstructive, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillar Palatal ImplantsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime Sleepiness (ESS)
Apnea/Hypopnea Index (AHI)
Secondary outcomes (3)
Sleep Related Quality of Life (FOSQ)
Reaction Time Testing (PVT)
Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startOct 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Xomed, Inc.
- Investigators
- David L Steward, MD, Principal investigator, University Ear, Nose and Throat Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307957
- Sponsor's protocol ID
- 05-08-14-1
- Status last verified
- Dec 2007
- First submitted
- 27 Mar 2006
- Last updated
- 12 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00307957
- Acronym / sponsor ID
- 05-08-14-1
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Daytime Sleepiness, Pillar Palatal Implants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Medtronic Xomed, Inc.
- Study start
- Oct 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 28 Mar 2006 (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 Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.
Detailed description
Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant group or a placebo/sham group.
In both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. Patients will also undergo reaction time testing on hand-held device similar to a pocket video game. At the three month visit, patients will return to the sleep lab for another sleep study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Body Mass Index equal to 32 or less
- Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30
- Symptoms of daytime sleepiness
Key exclusion criteria (18 listed)
- Septal deviation or nasal obstruction
- Nasal polyps
- Severe seasonal allergies
- Soft palate length insufficient to accommodate implants
- Fujita Modified Mallampati Class 3
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 |
|---|---|---|
| Pillar Palatal Implants | Device | – |
Primary outcome
Daytime Sleepiness (ESS)
Apnea/Hypopnea Index (AHI)
3 secondary outcomes
Sleep Related Quality of Life (FOSQ)
Reaction Time Testing (PVT)
Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)
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 Dec 2007.
- Manufacturer's website for more information on Pillar ImplantsLink provided by the sponsor.
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
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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.
David L Steward, MD principal investigator
University Ear, Nose and Throat Specialists
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pillar Palatal Implants in people with Obstructive Sleep Apnea, run by University of Cincinnati at 3 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 4 inclusion and 18 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 Dec 2007. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Daytime Sleepiness (ESS). 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?
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 Dec 2007.