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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Placebo-Controlled Study of the Pillar® Palatal Implant System With CPAP

Conditions
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Obstructive Sleep Apnea (OSA)

Intervention / Treatment
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* Device: Pillar Palatal Implant System
* Device: Sham system


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palatal Implants<br>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<br>* 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.<br>* Other names: palatal implants;|
| Sham Comparator: Sham procedure<br>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<br>* 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.<br>* Other names: palatal implants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 3 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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). | 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. | 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. | 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. | Baseline and 4 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, continuous positive air pressure