Randomized Placebo-Controlled Study of the Pillar® Palatal Implant System With CPAP
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Medtronic Xomed, Inc.
- Enrollment
- 51
- Locations
- 13
- Primary Endpoint
- Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration
Study Overview
Brief 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
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.(Baseline and 4 months post-procedure)
- Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)(Baseline and 4 months post-procedure)
- Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.(Baseline and 4 months post-procedure)
- Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.(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.(Baseline and 4 months post-procedure)
- Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)(Baseline and 4 months post-procedure)