Clinical trial NCT00730041: Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea
Official title: Randomized Placebo-Controlled Study of the Pillar® Palatal Implant System With CPAP
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: obstructive sleep apnea
continuous positive air pressure
Lead sponsor: Medtronic Xomed, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2008-08-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration
timeFrame: Baseline and 3 months post-procedure
Secondary outcomes:
measure: Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.
timeFrame: Baseline and 4 months post-procedure
measure: Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)
timeFrame: Baseline and 4 months post-procedure
measure: Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.
timeFrame: Baseline and 4 months post-procedure
measure: Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.
timeFrame: Baseline and 4 months post-procedure
measure: Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.
timeFrame: Baseline and 4 months post-procedure
measure: Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)
timeFrame: Baseline and 4 months post-procedure
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Center for Sleep Medicine
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Denver
country: United States
facility: Sleep Center at National Jewish Medical Center
state: Colorado
city: Baton Rouge
country: United States
facility: Louisiana Sleep Foundation
state: Louisiana
city: St. Paul
country: United States
facility: Regions Hospital; Health Partners Sleep Health Center
state: Minnesota
city: New York
country: United States
facility: NYU Sleep Disorders Center
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: NYU Sleep Disorders Center
name: David M Rapoport, MD
role: PRINCIPAL_INVESTIGATOR
References: