Trial Outcomes & Findings for Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea (NCT NCT00730041)
NCT ID: NCT00730041
Last Updated: 2010-01-12
Results Overview
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.
TERMINATED
PHASE4
51 participants
Baseline and 3 months post-procedure
2010-01-12
Participant Flow
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.
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.
Participant milestones
| Measure |
Pillar(R) Palatal Implants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Pillar(R) Palatal Implants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Pillar(R) Palatal Implants
n=26 Participants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=25 Participants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age Continuous
|
52.3 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
51.1 years
STANDARD_DEVIATION 9.0 • n=107 Participants
|
51.7 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
25 participants
n=107 Participants
|
51 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months post-procedurePopulation: 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.
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.
Outcome measures
| Measure |
Pillar(R) Palatal Implants
n=26 Participants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=24 Participants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
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
|
10.9 centimeters of water (cm H2O)
Standard Deviation 2.6
|
|
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
|
9.8 centimeters of water (cm H2O)
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and 4 months post-procedurePopulation: Two participants in the sham group became lost to follow-up and did not return for the final follow-up.
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).
Outcome measures
| Measure |
Pillar(R) Palatal Implants
n=26 Participants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=23 Participants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.
Baseline Score
|
3.5 Scores on a Scale
Standard Deviation 2.1
|
3.2 Scores on a Scale
Standard Deviation 1.8
|
|
Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.
Post 90-day PSG Score (4 months post-procedure)
|
5.6 Scores on a Scale
Standard Deviation 2.5
|
4.3 Scores on a Scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline and 4 months post-procedurePopulation: Five participants in the sham group did not return their SmartCards at the final study visit.
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.
Outcome measures
| Measure |
Pillar(R) Palatal Implants
n=26 Participants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=20 Participants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)
Baseline Score
|
46.8 Units on a scale
Standard Deviation 15.1
|
47.2 Units on a scale
Standard Deviation 7.2
|
|
Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)
Post 90-day PSG Score (4 months post-procedure)
|
48.8 Units on a scale
Standard Deviation 18.4
|
50.8 Units on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline and 4 months post-procedurePopulation: Two participants in the sham group became lost to follow-up and did not return for the final follow-up.
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).
Outcome measures
| Measure |
Pillar(R) Palatal Implants
n=26 Participants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=23 Participants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.
Baseline Score
|
3.8 Scores on a Scale
Standard Deviation 2.3
|
4.2 Scores on a Scale
Standard Deviation 2.2
|
|
Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.
Post 90-day PSG Score (4 months post-procedure)
|
6.5 Scores on a Scale
Standard Deviation 2.3
|
5.0 Scores on a Scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline and 4 months post-procedurePopulation: Two participants became lost to follow-up and did not return for the final study visit.
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.
Outcome measures
| Measure |
Pillar(R) Palatal Implants
n=26 Participants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=23 Participants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.
Baseline Score
|
10.7 Scores on a Scale
Standard Deviation 5.7
|
11.3 Scores on a Scale
Standard Deviation 5.9
|
|
Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.
Post 90-day PSG Score (4 months post-procedure)
|
7.9 Scores on a Scale
Standard Deviation 5.2
|
9.7 Scores on a Scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline and 4 months post-procedurePopulation: Two subjects became lost to follow-up and did not return for the final study visit.
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.
Outcome measures
| Measure |
Pillar(R) Palatal Implants
n=26 Participants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=23 Participants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.
Baseline Score
|
15.5 Scores on a Scale
Standard Deviation 2.9
|
15.5 Scores on a Scale
Standard Deviation 3.1
|
|
Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.
Post 90-day PSG Score (4 months post-procedure)
|
17.4 Scores on a Scale
Standard Deviation 2.4
|
16.0 Scores on a Scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline and 4 months post-procedurePopulation: Five participants in the sham group did not return their SmartCards at the final study visit.
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.
Outcome measures
| Measure |
Pillar(R) Palatal Implants
n=26 Participants
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=20 Participants
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)
Baseline Usage
|
6.0 Average hours per day of days used
Standard Deviation 2.5
|
5.2 Average hours per day of days used
Standard Deviation 1.9
|
|
Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)
Post 90-day PSG Usage (4 months post-procedure)
|
6.0 Average hours per day of days used
Standard Deviation 2.4
|
5.2 Average hours per day of days used
Standard Deviation 2.1
|
Adverse Events
Pillar(R) Palatal Implants
Sham Procedure With no Implants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pillar(R) Palatal Implants
n=26 participants at risk
Pillar Implants in combination with continuous positive airway pressure (CPAP)
|
Sham Procedure With no Implants
n=25 participants at risk
Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Sore or scratchy throat at site of needle insertion
|
50.0%
13/26 • Number of events 13 • 4 months (from implant to the subject's final follow-up visit at approximately 4 months post-implant procedure)
Subjects were asked at the 7 day follow-up and the 4 month follow-up about any changes in health they experienced since the implant/sham procedure. They were also instructed to contact the study physician or coordinator if they had any problems between visits. Each subject's medical records were reviewed for adverse events at monitoring visits.
|
28.0%
7/25 • Number of events 7 • 4 months (from implant to the subject's final follow-up visit at approximately 4 months post-implant procedure)
Subjects were asked at the 7 day follow-up and the 4 month follow-up about any changes in health they experienced since the implant/sham procedure. They were also instructed to contact the study physician or coordinator if they had any problems between visits. Each subject's medical records were reviewed for adverse events at monitoring visits.
|
|
Injury, poisoning and procedural complications
Mild bleeding at the site of needle insertion during the procedure
|
7.7%
2/26 • Number of events 2 • 4 months (from implant to the subject's final follow-up visit at approximately 4 months post-implant procedure)
Subjects were asked at the 7 day follow-up and the 4 month follow-up about any changes in health they experienced since the implant/sham procedure. They were also instructed to contact the study physician or coordinator if they had any problems between visits. Each subject's medical records were reviewed for adverse events at monitoring visits.
|
4.0%
1/25 • Number of events 1 • 4 months (from implant to the subject's final follow-up visit at approximately 4 months post-implant procedure)
Subjects were asked at the 7 day follow-up and the 4 month follow-up about any changes in health they experienced since the implant/sham procedure. They were also instructed to contact the study physician or coordinator if they had any problems between visits. Each subject's medical records were reviewed for adverse events at monitoring visits.
|
|
General disorders
Medication reaction (non-study related, non-life threatening)
|
7.7%
2/26 • Number of events 2 • 4 months (from implant to the subject's final follow-up visit at approximately 4 months post-implant procedure)
Subjects were asked at the 7 day follow-up and the 4 month follow-up about any changes in health they experienced since the implant/sham procedure. They were also instructed to contact the study physician or coordinator if they had any problems between visits. Each subject's medical records were reviewed for adverse events at monitoring visits.
|
4.0%
1/25 • Number of events 1 • 4 months (from implant to the subject's final follow-up visit at approximately 4 months post-implant procedure)
Subjects were asked at the 7 day follow-up and the 4 month follow-up about any changes in health they experienced since the implant/sham procedure. They were also instructed to contact the study physician or coordinator if they had any problems between visits. Each subject's medical records were reviewed for adverse events at monitoring visits.
|
|
Infections and infestations
Sinus infection
|
7.7%
2/26 • Number of events 2 • 4 months (from implant to the subject's final follow-up visit at approximately 4 months post-implant procedure)
Subjects were asked at the 7 day follow-up and the 4 month follow-up about any changes in health they experienced since the implant/sham procedure. They were also instructed to contact the study physician or coordinator if they had any problems between visits. Each subject's medical records were reviewed for adverse events at monitoring visits.
|
0.00%
0/25 • 4 months (from implant to the subject's final follow-up visit at approximately 4 months post-implant procedure)
Subjects were asked at the 7 day follow-up and the 4 month follow-up about any changes in health they experienced since the implant/sham procedure. They were also instructed to contact the study physician or coordinator if they had any problems between visits. Each subject's medical records were reviewed for adverse events at monitoring visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agree to submit copies of proposed manuscripts or abstracts to sponsor at least 45 days in advance of public release. If sponsor requests or requires changes, an additional 90 days are allowed for this. Upon completion of the last subject follow-up for the Evaluation, a period of one year shall be reserved for publication of the entire trial results. No individual investigator may publish their individual site results prior to the publication of the group data.
- Publication restrictions are in place
Restriction type: OTHER