Obstructive Sleep Apnea (OSA)Phase 4Pillar-CPAPNCT00730041
Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea
A Phase 4 study testing Pillar Palatal Implant System in people with Obstructive Sleep Apnea (OSA), run by Medtronic Xomed, Inc. at 7 sites in United States.
Trial summary
The study will be done for the following purposes: to see if Pillar implants in combination with CPAP therapy can help people with their OSA by decreasing the CPAP pressures to find out if receiving Pillar implants will increase CPAP use Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Pillar Palatal Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2007to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- OSA documented by sleep study demonstrating AHI > 10, where hypopneas are defined by Medicare criteria requiring a 4% desaturation
- Adequate CPAP therapy titration (residual AHI < 5) resulting in a therapeutic pressure ≥7 cm H20 from baseline PSG
- Currently using or willing to change to Respironics CPAP device (without A-flex, C-flex and Bi-flex enabled) with SmartCard technology
- Currently dissatisfied with CPAP therapy
Who cannot join
- Uses full face mask
- Soft palate length insufficient to accommodate 18mm implants as measured from the hard palate junction to the base of the uvula (<25 mm)
- Drug abuse or alcoholism in the year prior to enrollment as assessed by history
- Inconsistent use of sleeping medications (1 or 2 nights per week)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Louisiana Sleep Foundation
Baton Rouge, Louisiana, 70809
Alta Bates Summit Medical Center
Berkeley, California, 94704
Medical University of South Carolina
Charleston, South Carolina, 29425
Sleep Center at National Jewish Medical Center
Denver, Colorado, 80206
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, 72205
NYU Sleep Disorders Center
New York, New York, 10016
Regions Hospital; Health Partners Sleep Health Center
Saint Paul, Minnesota, 55101-2595
About this study
Official title: Randomized Placebo-Controlled Study of the Pillar® Palatal Implant System With CPAP
The study will be done for the following purposes:
- to see if Pillar implants in combination with CPAP therapy can help people with their OSA by decreasing the CPAP pressures
- to find out if receiving Pillar implants will increase CPAP use
Read the detailed description
Obstructive Sleep Apnea (OSA) is the intermittent cessation of breathing during sleep due to the collapse of the pharyngeal airway. As reported in the April 2004 Journal of the American Medical Association, it is estimated that 59 million people in the United States suffer OSA symptoms. OSA is typically diagnosed through an overnight sleep study (polysomnogram or PSG) in a sleep laboratory or a portable monitoring system. The American Academy of Sleep Medicine's (AASM) recommended treatment for patients with OSA is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to treat OSA by preventing collapse of the upper airway during sleep with the use of positive pressure. Compliance with CPAP therapy may be a problem as fewer than 50% of patients using CPAP have been considered "regular" users due to a variety of factors such as claustrophobia, nasal stuffiness, social factors, and inconvenience.
The Pillar® Palatal Implant System is currently commercially available in the United States, Europe, and other countries to treat habitual snoring and mild to moderate OSA. It is a minimally invasive, well-tolerated procedure that reduces the flexibility of the soft palate and increases its stiffness, which reduces snoring and may limit the palate's ability to collapse into the airway during sleep contributing to clinical episodes of OSA.
The Pillar system consists of a delivery system and an implant. The delivery system is comprised of a disposable handle and needle assembly that allows for positioning and placement of the implants within the soft palate. The 18mm x 2mm implant is a cylindrical shaped segment of braided polyester filaments that is intended for permanent implantation into the soft palate. The needle of the delivery system is inserted into the soft palate, near the hard palate junction. A sliding thumb switch is retracted to deploy the implant. The first implant is placed midline and two additional implants are placed, one on each side approximately 2mm from the midline implant, for a total of three implants.
An antiseptic rinse is recommended pre-procedure and an appropriate broad-spectrum antibiotic should be given both pre and post-procedurally. Local anesthesia is used in all patients. Pain medication is suggested to manage discomfort in the immediate post-operative period.
While the Pillar procedure can be effective in the treatment of mild to moderate OSA, its effect in combination with CPAP treatment has never been studied. In this study, the treatment of OSA using the Pillar procedure in combination with standard CPAP treatment vs. sham procedure in combination with standard CPAP treatment will be investigated. All subjects will be asked to continue their normal use of CPAP treatment during the study. The study will evaluate whether or not the Pillar implants allow less therapeutic pressure to be used in treating the OSA and if less pressure translates to increased usage.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Pillar Palatal Implant System, Sham system
- Keywords
- obstructive sleep apnea, continuous positive air pressure
- 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.
Pillar Palatal Implant SystemDevice
Also called soft palate implants, palatal implants
The Pillar system is intended as an initial treatment option for mild to moderate OSA. It consists of a delivery system and an implant. The delivery system is comprised of a disposable handle and needle assembly that allows for positioning and placement of the implant within the soft palate of the mouth. The 18mm x 2mm implant is a cylindrical shaped segment of braided polyester filaments that is intended for permanent implantation into the soft palate. The implant is pre-loaded into the needle. Three implants are placed in each subject under local anesthesia. Because implants are not able to be seen in the soft palate tissue, the physician is unable to see if an implant is placed or not placed and thus is blinded to the intervention type.
Sham systemDevice
Also called soft palate implants, palatal implants
The Pillar system consists of a delivery system and an implant. The only difference between the treatment and sham arm in this study is that the sham delivery device is not pre-loaded with the implant. Otherwise the appearance, manufacturing and function of the delivery devices are identical. Three insertions are made, but no implants are actually deployed during the procedure. Because implants are not able to be seen in the soft palate tissue, the physician is unable to see if an implant is placed or not placed and thus is blinded to the intervention type.
| Study group | Role | What they receive |
|---|---|---|
| Palatal Implants | Active comparator | Pillar(R) Palatal Implants in combination with continuous positive airway pressure (CPAP) in subjects diagnosed with obstructive sleep apnea (OSA) Receives: Device: Pillar Palatal Implant System |
| Sham procedure | Sham comparator | Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP) in subjects diagnosed with obstructive sleep apnea (OSA) Receives: Device: Sham system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration
The American Academy of Sleep Medicine's (AASM) recommended treatment for patients with obstructive sleep apnea (OSA) is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to prevent collapse of the upper airway. CPAP pressures are measured in centimeters of water, and range in whole numbers from 4cm H2O to 20cm H2O. The therapeutic pressure is usually determined during overnight polysomnography and usually performed by a technician.
Measured: Baseline and 3 months post-procedure
Secondary outcomes (6)
Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.
The candidate was asked to complete a questionnaire that included a VAS describing CPAP therapy comfort. Scores ranged from 0 (very uncomfortable) to 10 (very comfortable).
Measured: Baseline and 4 months post-procedure
Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)
Leak is an indicator of mask/headgear fit and can also be used to substantiate or contradict an assigned therapeutic pressure. Total leak is the sum of intentional leak to prevent carbon dioxide rebreathing and unintentional leak. Each mask has a known amount of leak (the intentional leak), and subjects were instructed not to changes masks to minimize this variable. Approximate range is 0-100, and the amount of leak increases as the number increases. Average leak values are in the 20-50 liters per minute range. The CPAP machine records leak data during each night of usage and can average.
Measured: Baseline and 4 months post-procedure
Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.
The candidate was asked to complete a questionnaire that included a VAS describing CPAP satisfaction. Scores ranged from 0 (very unsatisfied) to 10 (very satisfied).
Measured: Baseline and 4 months post-procedure
Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.
The Epworth Sleepiness Scale (ESS) was included in the subject questionnaire as a tool to further assess the quality of sleep for each subject throughout the follow-up period. This scale is a validated clinical indicator that quantifies the patient's chance of falling asleep during eight different activities of daily living such as reading, talking, resting and driving. Each of the eight questions has four possible responses: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing to 3 = high chance of dozing, for a possible maximum score of 24.
Measured: Baseline and 4 months post-procedure
Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.
The FOSQ can assess the quality of sleep and this scale is a validated measure the impact of excessive sleepiness on multiple activities of daily living. It has 30 questions in 5 subgroups of general productivity (8 questions), social outcome (2), activity level (9), vigilance (7), and intimate relationships and sexual activity (4). Responses for each question range from 1 (extreme difficulty or low activity level) to 4 (no difficulty or high activity level) for each subgroup. A mean is calculated for each subgroup, and then the mean of the subgroups is calculated and multiplied by 5.
Measured: Baseline and 4 months post-procedure
Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)
The CPAP machine has an internal clock/calendar, and capabilities to record usage onto a removable data card the size of a credit card. Data is recorded from the first time the machine is turned on to the last time the machine is turned on during a given period in which the SmartCard is present in the machine. The SmartCard records all days during the given period and keeps track of days in which the CPAP machine is used and days in which it is not used. The SmartCard data is able to be downloaded to a computer for review and analysis.
Measured: Baseline and 4 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionMar 2009
Why it stopped: Medtronic acquisition of Restore Medical, business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Xomed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- David M Rapoport, MD, Principal investigator, NYU Sleep Disorders Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730041
- Sponsor's protocol ID
- 845
- Acronym
- Pillar-CPAP
- Status last verified
- Jan 2010
- First submitted
- 6 Aug 2008
- Last updated
- 12 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Study of the Pillar® Palatal Implant System With CPAP
- ClinicalTrials.gov ID
- NCT00730041
- Acronym / sponsor ID
- Pillar-CPAP / 845
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- obstructive sleep apnea, continuous positive air pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medtronic acquisition of Restore Medical, business decision
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medtronic Xomed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 9 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be done for the following purposes:
- to see if Pillar implants in combination with CPAP therapy can help people with their OSA by decreasing the CPAP pressures
- to find out if receiving Pillar implants will increase CPAP use
Detailed description
Obstructive Sleep Apnea (OSA) is the intermittent cessation of breathing during sleep due to the collapse of the pharyngeal airway. As reported in the April 2004 Journal of the American Medical Association, it is estimated that 59 million people in the United States suffer OSA symptoms. OSA is typically diagnosed through an overnight sleep study (polysomnogram or PSG) in a sleep laboratory or a portable monitoring system. The American Academy of Sleep Medicine's (AASM) recommended treatment for patients with OSA is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to treat OSA by preventing collapse of the upper airway during sleep with the use of positive pressure. Compliance with CPAP therapy may be a problem as fewer than 50% of patients using CPAP have been considered "regular" users due to a variety of factors such as claustrophobia, nasal stuffiness, social factors, and inconvenience.
The Pillar® Palatal Implant System is currently commercially available in the United States, Europe, and other countries to treat habitual snoring and mild to moderate OSA. It is a minimally invasive, well-tolerated procedure that reduces the flexibility of the soft palate and increases its stiffness, which reduces snoring and may limit the palate's ability to collapse into the airway during sleep contributing to clinical episodes of OSA.
The Pillar system consists of a delivery system and an implant. The delivery system is comprised of a disposable handle and needle assembly that allows for positioning and placement of the implants within the soft palate. The 18mm x 2mm implant is a cylindrical shaped segment of braided polyester filaments that is intended for permanent implantation into the soft palate. The needle of the delivery system is inserted into the soft palate, near the hard palate junction. A sliding thumb switch is retracted to deploy the implant. The first implant is placed midline and two additional implants are placed, one on each side approximately 2mm from the midline implant, for a total of three implants.
An antiseptic rinse is recommended pre-procedure and an appropriate broad-spectrum antibiotic should be given both pre and post-procedurally. Local anesthesia is used in all patients. Pain medication is suggested to manage discomfort in the immediate post-operative period.
While the Pillar procedure can be effective in the treatment of mild to moderate OSA, its effect in combination with CPAP treatment has never been studied. In this study, the treatment of OSA using the Pillar procedure in combination with standard CPAP treatment vs. sham procedure in combination with standard CPAP treatment will be investigated. All subjects will be asked to continue their normal use of CPAP treatment during the study. The study will evaluate whether or not the Pillar implants allow less therapeutic pressure to be used in treating the OSA and if less pressure translates to increased usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palatal Implants | Active comparator | Device: Pillar Palatal Implant SystemPillar(R) Palatal Implants in combination with continuous positive airway pressure (CPAP) in subjects diagnosed with obstructive sleep apnea (OSA) |
| Sham procedure | Sham comparator | Device: Sham systemSham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP) in subjects diagnosed with obstructive sleep apnea (OSA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- OSA documented by sleep study demonstrating AHI > 10, where hypopneas are defined by Medicare criteria requiring a 4% desaturation
- Adequate CPAP therapy titration (residual AHI < 5) resulting in a therapeutic pressure ≥7 cm H20 from baseline PSG
- Currently using or willing to change to Respironics CPAP device (without A-flex, C-flex and Bi-flex enabled) with SmartCard technology
- Currently dissatisfied with CPAP therapy
Key exclusion criteria (4 listed)
- Uses full face mask
- Soft palate length insufficient to accommodate 18mm implants as measured from the hard palate junction to the base of the uvula (<25 mm)
- Drug abuse or alcoholism in the year prior to enrollment as assessed by history
- Inconsistent use of sleeping medications (1 or 2 nights per week)
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 Implant SystemAlso: soft palate implants, palatal implantsThe Pillar system is intended as an initial treatment option for mild to moderate OSA. It consists of a delivery system and an implant. The delivery system is comprised of a disposable handle and needle assembly that allows for positioning and placement of the implant within the soft palate of the mouth. The 18mm x 2mm implant is a cylindrical shaped segment of braided polyester filaments that is intended for permanent implantation into the soft palate. The implant is pre-loaded into the needle. Three implants are placed in each subject under local anesthesia. Because implants are not able to be seen in the soft palate tissue, the physician is unable to see if an implant is placed or not placed and thus is blinded to the intervention type. | Device | Palatal Implants |
| Sham systemAlso: soft palate implants, palatal implantsThe Pillar system consists of a delivery system and an implant. The only difference between the treatment and sham arm in this study is that the sham delivery device is not pre-loaded with the implant. Otherwise the appearance, manufacturing and function of the delivery devices are identical. Three insertions are made, but no implants are actually deployed during the procedure. Because implants are not able to be seen in the soft palate tissue, the physician is unable to see if an implant is placed or not placed and thus is blinded to the intervention type. | Device | Sham procedure |
Primary outcome
Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration
Time frame: Baseline and 3 months post-procedure
The American Academy of Sleep Medicine's (AASM) recommended treatment for patients with obstructive sleep apnea (OSA) is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to prevent collapse of the upper airway. CPAP pressures are measured in centimeters of water, and range in whole numbers from 4cm H2O to 20cm H2O. The therapeutic pressure is usually determined during overnight polysomnography and usually performed by a technician.
6 secondary outcomes
Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.
Time frame: Baseline and 4 months post-procedure
Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)
Time frame: Baseline and 4 months post-procedure
Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.
Time frame: Baseline and 4 months post-procedure
Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.
Time frame: Baseline and 4 months post-procedure
Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.
Time frame: Baseline and 4 months post-procedure
Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)
Time frame: Baseline and 4 months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 M Rapoport, MD principal investigator
NYU Sleep Disorders Center
7 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 Implant System in people with Obstructive Sleep Apnea (OSA), run by Medtronic Xomed, Inc. at 7 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 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: stopped early, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration (time frame: Baseline and 3 months post-procedure). 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 Jan 2010.