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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730041

Acronym

Pillar-CPAP

Enrollment

Registered

2008-08-08

Start date

2007-11-30

Completion date

2009-03-31

Last updated

2010-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

obstructive sleep apnea, continuous positive air pressure

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.

Interventions

DEVICEPillar 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.

DEVICESham 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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).
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.
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.

Countries

United States

Participant flow

Recruitment details

All initial study candidates were recruited from the Investigator's general patient population and related physician referral base. The Investigator or designee screened each candidate to ensure that all inclusion and exclusion criteria were met.

Pre-assignment details

After initial screening, all subjects had a polysomnogram (PSG) with continuous positive airway pressure (CPAP) titration to determine the therapeutic pressure. Subjects collected a minimum of two weeks of SmartCard data using CPAP machine prior to the intervention in order to establish baseline usage info. Group was determined at the intervention.

Participants by arm

Arm	Count
Pillar(R) Palatal Implants Pillar Implants in combination with continuous positive airway pressure (CPAP)	26
Sham Procedure With no Implants Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)	25
Total	51

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	2

Baseline characteristics

Characteristic	Sham Procedure With no Implants	Pillar(R) Palatal Implants	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	2 Participants	3 Participants	5 Participants
Age, Categorical Between 18 and 65 years	23 Participants	23 Participants	46 Participants
Age Continuous	51.1 years STANDARD_DEVIATION 9	52.3 years STANDARD_DEVIATION 10.3	51.7 years STANDARD_DEVIATION 9.6
Region of Enrollment United States	25 participants	26 participants	51 participants
Sex: Female, Male Female	4 Participants	4 Participants	8 Participants
Sex: Female, Male Male	21 Participants	22 Participants	43 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	17 / 26	9 / 25
serious Total, serious adverse events	0 / 26	0 / 25

Outcome results

Primary

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.

Time frame: Baseline and 3 months post-procedure

Population: 50 of 51 total participants returned to the sleep lab for the 90-day PSG. All 50 participants are part of the primary endpoint analysis.

Arm	Measure	Group	Value (MEAN)	Dispersion
Pillar(R) Palatal Implants	Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration	Assigned Pressure at Baseline	10.9 centimeters of water (cm H2O)	Standard Deviation 2.7
Pillar(R) Palatal Implants	Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration	Assigned Pressure at 90 days	10.3 centimeters of water (cm H2O)	Standard Deviation 2.4
Sham Procedure With no Implants	Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration	Assigned Pressure at Baseline	10.9 centimeters of water (cm H2O)	Standard Deviation 2.6
Sham Procedure With no Implants	Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration	Assigned Pressure at 90 days	9.8 centimeters of water (cm H2O)	Standard Deviation 3

Secondary

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.