Trial Outcomes & Findings for Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) (NCT NCT00750165)
NCT ID: NCT00750165
Last Updated: 2019-04-09
Results Overview
The Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour.
COMPLETED
NA
32 participants
1 night
2019-04-09
Participant Flow
Participant milestones
| Measure |
Titration Night
Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device
SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Titration Night
n=21 Participants
Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device
SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
|
|---|---|
|
Age, Continuous
|
51 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 nightThe Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour.
Outcome measures
| Measure |
Titration Night
n=21 Participants
Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device
SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
|
|---|---|
|
Apnea Hypopnea Index (AHI)
|
2.4 events per hour
Interval 0.0 to 8.6
|
SECONDARY outcome
Timeframe: 1 NightOxygen saturation is a measurement of the amount of oxygen present in the blood. An oxygen saturation of less than 90% is considered low, resulting in hypoxemia. Normal blood oxygen level is considered between 95-100%.
Outcome measures
| Measure |
Titration Night
n=21 Participants
Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device
SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
|
|---|---|
|
Percent of Time With Less Than 90% Oxygen Saturation
|
1.4 percentage of total sleep time
Interval 0.0 to 24.7
|
SECONDARY outcome
Timeframe: 1 NightSimilar to AHI, the RDI is a calculation of the total number of respiratory disturbances in sleep. The calculation includes apneas and hypopneas, but also includes respiratory effort related arousals.
Outcome measures
| Measure |
Titration Night
n=21 Participants
Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device
SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
|
|---|---|
|
Respiratory Disturbance Index (RDI)
|
7.1 events per hour
Interval 1.5 to 13.2
|
SECONDARY outcome
Timeframe: 1 NightThe Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour.
Outcome measures
| Measure |
Titration Night
n=21 Participants
Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device
SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
|
|---|---|
|
Arousal Index (AI)
|
16.2 events per hour
Interval 4.9 to 32.9
|
Adverse Events
Titration Night
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Titration Night
n=21 participants at risk
Treatment with the Fisher \& Paykel Sleep Style 200 Auto CPAP device
SleepStyle 200 Auto Series CPAP Humidifier: The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Mask Discomfort
|
4.8%
1/21 • Number of events 1 • 1 night
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Exhaling Due to Pressure
|
4.8%
1/21 • Number of events 1 • 1 night
|
|
Investigations
Disruption of Sleep Due to Lab Environment
|
19.0%
4/21 • Number of events 4 • 1 night
|
Additional Information
Clinical Research Scientist
Fisher and Paykel Healthcare
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place