Obstructive Sleep Apnea
Conditions
Keywords
cPAP, SenseAwake
Brief summary
This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial with crossover design, comparing compliance on standard APAP with compliance using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.
Interventions
DEVICESensAwake™ modification
SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep.
Sponsors
Fisher and Paykel Healthcare
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.
Exclusion criteria
1. Unstable cardiovascular disease (untreated or resistant hypertension acceptable). 2. Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator. 3. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements. 4. Any known factor that result in mask taken of such as skin discomfort, nasal obstruction, water dripping inside the tubing system etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of Auto-CPAP Therapy | 2 weeks | Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Pressures of Auto-CPAP Machine | 2 weeks | Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine) |
| 90th Percentile Pressures of Auto-CPAP Machine | 2 weeks | 90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) |
| Average Leaks of Auto-CPAP Machine | 2 weeks | Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) |
| 90th Percentile Leaks of Auto-CPAP Machine | 2 weeks | Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) |
| Residual Apnea-Hypopnea Index (AHI) | 2 weeks | Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy. |
| Average SA Detections | 2 weeks | Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine) |
| Percentage of Day Used of Auto-CPAP Machine | 2 weeks | Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) |
| Pittsburgh Sleep Quality Index (PSQI) | 2 weeks | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality. |
| Epworth Sleepiness Score (ESS) | 2 weeks | The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness. |
| Nasal Obstruction Symptom Evaluation (NOSE) | 2 weeks | The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction. |
| Time Used of Auto-CPAP Machine | 2 weeks | Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) |
Participant flow
Recruitment details
March 2015 to Mar 2016, at medical clinic.
Participants by arm
| Arm | Count |
|---|---|
| CPAP w/SensAwake First, Then CPAP w/o SensAwake Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period. | 12 |
| CPAP w/o SensAwake First, Then CPAP w/SensAwake Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | CPAP w/o SensAwake First, Then CPAP w/SensAwake | CPAP w/SensAwake First, Then CPAP w/o SensAwake | Total |
|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 12 | 47.6 years STANDARD_DEVIATION 10.9 | 44.0 years STANDARD_DEVIATION 11.7 |
| Apnea-hypopnea index (AHI) | 54.0 events per hour STANDARD_DEVIATION 35.3 | 55.3 events per hour STANDARD_DEVIATION 30.8 | 54.6 events per hour STANDARD_DEVIATION 32.5 |
| Average used time of CPAP | 227.9 minutes STANDARD_DEVIATION 104.1 | 187.4 minutes STANDARD_DEVIATION 104.6 | 208.5 minutes STANDARD_DEVIATION 104.2 |
| Body Mass Index (BMI) | 32.9 kg/m2 STANDARD_DEVIATION 6.9 | 31.8 kg/m2 STANDARD_DEVIATION 4.3 | 32.4 kg/m2 STANDARD_DEVIATION 5.7 |
| Compliance of CPAP | 46.2 % STANDARD_DEVIATION 30.6 | 31.9 % STANDARD_DEVIATION 31.9 | 39.3 % STANDARD_DEVIATION 31.4 |
| Deep sleep - Stage 3 | 4.4 % (percentage of minutes of stage 3) STANDARD_DEVIATION 5.6 | 6.1 % (percentage of minutes of stage 3) STANDARD_DEVIATION 10.4 | 5.2 % (percentage of minutes of stage 3) STANDARD_DEVIATION 8 |
| Epworth Sleepiness Scale (ESS) | 13.1 units on a scale STANDARD_DEVIATION 6.7 | 13.3 units on a scale STANDARD_DEVIATION 5.5 | 13.2 units on a scale STANDARD_DEVIATION 6 |
| Nasal Obstruction Symptom Evaluation (NOSE) | 15.6 units on a scale STANDARD_DEVIATION 8.4 | 13.5 units on a scale STANDARD_DEVIATION 6.8 | 14.6 units on a scale STANDARD_DEVIATION 7.6 |
| Neck Circumference (NC) | 41.0 cm STANDARD_DEVIATION 2.2 | 42.3 cm STANDARD_DEVIATION 2.1 | 41.6 cm STANDARD_DEVIATION 2.2 |
| Pittsburgh Sleep Quality Index (PSQI) | 10.1 units on a scale STANDARD_DEVIATION 3.8 | 7.4 units on a scale STANDARD_DEVIATION 2.3 | 8.8 units on a scale STANDARD_DEVIATION 3.4 |
| Residual AHI under CPAP Tx | 4.4 events per hour STANDARD_DEVIATION 2.8 | 2.9 events per hour STANDARD_DEVIATION 1.3 | 3.7 events per hour STANDARD_DEVIATION 2.3 |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
| Sleep efficiency | 73.0 % (percentage of minutes slept) STANDARD_DEVIATION 21.3 | 82.0 % (percentage of minutes slept) STANDARD_DEVIATION 8.9 | 77.1 % (percentage of minutes slept) STANDARD_DEVIATION 17.1 |
| Total sleep time | 276.2 minutes STANDARD_DEVIATION 79.2 | 301.0 minutes STANDARD_DEVIATION 34.2 | 287.6 minutes STANDARD_DEVIATION 62.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Compliance of Auto-CPAP Therapy
Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Compliance of Auto-CPAP Therapy | 41.8 percentage of nights | Standard Deviation 35 |
| SA OFF | Compliance of Auto-CPAP Therapy | 39.7 percentage of nights | Standard Deviation 32.6 |
Secondary
90th Percentile Leaks of Auto-CPAP Machine
Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | 90th Percentile Leaks of Auto-CPAP Machine | 57.6 liters per minute | Standard Deviation 24.7 |
| SA OFF | 90th Percentile Leaks of Auto-CPAP Machine | 58.9 liters per minute | Standard Deviation 26 |
Secondary
90th Percentile Pressures of Auto-CPAP Machine
90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | 90th Percentile Pressures of Auto-CPAP Machine | 8.6 cmH2O | Standard Deviation 3 |
| SA OFF | 90th Percentile Pressures of Auto-CPAP Machine | 9.2 cmH2O | Standard Deviation 2.9 |
Secondary
Average Leaks of Auto-CPAP Machine
Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Average Leaks of Auto-CPAP Machine | 41.3 liters per minute | Standard Deviation 20.1 |
| SA OFF | Average Leaks of Auto-CPAP Machine | 44.6 liters per minute | Standard Deviation 22.5 |
Secondary
Average Pressures of Auto-CPAP Machine
Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Average Pressures of Auto-CPAP Machine | 6.9 cmH2O | Standard Deviation 2.7 |
| SA OFF | Average Pressures of Auto-CPAP Machine | 7.3 cmH2O | Standard Deviation 2.6 |
Secondary
Average SA Detections
Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Average SA Detections | 2.1 times/hour | Standard Deviation 0.9 |
| SA OFF | Average SA Detections | 0 times/hour | Standard Deviation 0 |
Secondary
Epworth Sleepiness Score (ESS)
The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Epworth Sleepiness Score (ESS) | 11.1 units on a scale | Standard Deviation 6.1 |
| SA OFF | Epworth Sleepiness Score (ESS) | 12.1 units on a scale | Standard Deviation 7.2 |
Secondary
Nasal Obstruction Symptom Evaluation (NOSE)
The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Nasal Obstruction Symptom Evaluation (NOSE) | 14.6 units on a scale | Standard Deviation 8.1 |
| SA OFF | Nasal Obstruction Symptom Evaluation (NOSE) | 13.3 units on a scale | Standard Deviation 6.7 |
Secondary
Percentage of Day Used of Auto-CPAP Machine
Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Percentage of Day Used of Auto-CPAP Machine | 87.1 Percentage of days | Standard Deviation 13.8 |
| SA OFF | Percentage of Day Used of Auto-CPAP Machine | 88.1 Percentage of days | Standard Deviation 11.2 |
Secondary
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Pittsburgh Sleep Quality Index (PSQI) | 8.0 units on a scale | Standard Deviation 2.6 |
| SA OFF | Pittsburgh Sleep Quality Index (PSQI) | 8.0 units on a scale | Standard Deviation 2.8 |
Secondary
Residual Apnea-Hypopnea Index (AHI)
Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Residual Apnea-Hypopnea Index (AHI) | 6.3 events per hour | Standard Deviation 6.7 |
| SA OFF | Residual Apnea-Hypopnea Index (AHI) | 5.0 events per hour | Standard Deviation 4.6 |
Secondary
Time Used of Auto-CPAP Machine
Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SA ON | Time Used of Auto-CPAP Machine | 213.1 minutes | Standard Deviation 99.4 |
| SA OFF | Time Used of Auto-CPAP Machine | 206.8 minutes | Standard Deviation 87.6 |