Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea

Phase 4

Terminated

Conditions: Obstructive Sleep Apnea (OSA)

Interventions: Device: Pillar Palatal Implant System
Device: Sham system

Registration Number: NCT00730041

Lead Sponsor: Medtronic Xomed, Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 51

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palatal Implants	Pillar Palatal Implant System	Pillar(R) Palatal Implants in combination with continuous positive airway pressure (CPAP) in subjects diagnosed with obstructive sleep apnea (OSA)
Sham procedure	Sham system	Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP) in subjects diagnosed with obstructive sleep apnea (OSA)

Primary Outcome Measures

Name	Time	Method
Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration	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 Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.	Baseline and 4 months post-procedure	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).
Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)	Baseline and 4 months post-procedure	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.
Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.	Baseline and 4 months post-procedure	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).
Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.	Baseline and 4 months post-procedure	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.
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	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.
Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)	Baseline and 4 months post-procedure	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.

Trial Locations

Locations (7): Alta Bates Summit Medical Center
🇺🇸
Berkeley, California, United States
Regions Hospital; Health Partners Sleep Health Center
🇺🇸
St. Paul, Minnesota, United States
Sleep Center at National Jewish Medical Center
🇺🇸
Denver, Colorado, United States
Arkansas Center for Sleep Medicine
🇺🇸
Little Rock, Arkansas, United States
NYU Sleep Disorders Center
🇺🇸
New York, New York, United States
Louisiana Sleep Foundation
🇺🇸
Baton Rouge, Louisiana, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States