Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea (Pillar-CPAP)

This study has been terminated.
(Medtronic acquisition of Restore Medical, business decision)
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Xomed, Inc.
ClinicalTrials.gov Identifier:
NCT00730041
First received: August 6, 2008
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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

Condition Intervention Phase
Obstructive Sleep Apnea (OSA)
Device: Pillar Palatal Implant System
Device: Sham system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Study of the Pillar® Palatal Implant System With CPAP

Resource links provided by NLM:


Further study details as provided by Medtronic Xomed, Inc.:

Primary Outcome Measures:
  • Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration [ Time Frame: Baseline and 3 months post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score. [ Time Frame: Baseline and 4 months post-procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction. [ Time Frame: Baseline and 4 months post-procedure ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness. [ Time Frame: Baseline and 4 months post-procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Palatal Implants
Pillar(R) Palatal Implants in combination with continuous positive airway pressure (CPAP) in subjects diagnosed with obstructive sleep apnea (OSA)
Device: Pillar Palatal Implant System
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.
Other Names:
  • soft palate implants
  • palatal implants
Sham Comparator: Sham procedure
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP) in subjects diagnosed with obstructive sleep apnea (OSA)
Device: Sham system
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.
Other Names:
  • soft palate implants
  • palatal implants

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730041

Locations
United States, Arkansas
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, United States, 72205
United States, California
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
United States, Colorado
Sleep Center at National Jewish Medical Center
Denver, Colorado, United States, 80206
United States, Louisiana
Louisiana Sleep Foundation
Baton Rouge, Louisiana, United States, 70809
United States, Minnesota
Regions Hospital; Health Partners Sleep Health Center
St. Paul, Minnesota, United States, 55101-2595
United States, New York
NYU Sleep Disorders Center
New York, New York, United States, 10016
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medtronic Xomed, Inc.
Medtronic
Investigators
Principal Investigator: David M Rapoport, MD NYU Sleep Disorders Center
  More Information

No publications provided

Responsible Party: David Hodge, Medtronic Inc.
ClinicalTrials.gov Identifier: NCT00730041     History of Changes
Other Study ID Numbers: 845
Study First Received: August 6, 2008
Results First Received: August 7, 2009
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Xomed, Inc.:
obstructive sleep apnea
continuous positive air pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 29, 2014