Obstructive Sleep Apnea
Conditions
Brief summary
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep. The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology. It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.
Interventions
DEVICESensAwake On
DEVICESensAwake Off
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour). * Successful in-lab titration polysomnography (PSG) * General (at home) sleep habits of: * At least 7 hours in bed on most nights * Lights out at 12 midnight or earlier * Fluency in both written and spoken English.
Exclusion criteria
* Participants prescribed and fitted with any PAP device in the past 2 years * Contraindicated for CPAP or AutoCPAP therapy. * Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator. * Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator. * Patients who are prescribed hypnotics and sedating medications. * Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months. * If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots. * If the physician objects to their patient taking part in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to CPAP Treatment | 2 weeks | Average used minutes (all days) taken from the CPAP device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daytime Sleepiness (Subjective Sleep Quality) | 4 weeks | Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime. |
| Insomnia Severity Index (Subjective Sleep Quality) | 4 weeks | Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe). |
| OSA Impact of Daily Life | 4 weeks | Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life. |
| Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity | 4 weeks | Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference. |
| Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change | 4 weeks | Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference. |
| OSA Impact of Daily Life (Fatigue) | 4 weeks | Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Leak | One night | The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device |
| Apnea Hypopnea Index (AHI) | 2 weeks | Collected through the device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants who were randomized to receive either SensAwake On or SensAwake Off | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 50.78 years STANDARD_DEVIATION 11.49 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 11 / 70 | 16 / 70 |
| serious Total, serious adverse events | 0 / 70 | 1 / 70 |
Outcome results
Primary
Adherence to CPAP Treatment
Average used minutes (all days) taken from the CPAP device.
Time frame: 2 weeks
Population: Adherence data could only be obtained for 61 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Adherence to CPAP Treatment | 272.672 mins | Standard Error 17.055 |
| SensAwake Off | Adherence to CPAP Treatment | 289.087 mins | Standard Error 15.239 |
Secondary
Daytime Sleepiness (Subjective Sleep Quality)
Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.
Time frame: 4 weeks
Population: Data for 65 participant were available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Daytime Sleepiness (Subjective Sleep Quality) | 6.9 units on a scale | Standard Error 0.6 |
| SensAwake Off | Daytime Sleepiness (Subjective Sleep Quality) | 6.4 units on a scale | Standard Error 0.6 |
Secondary
Insomnia Severity Index (Subjective Sleep Quality)
Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).
Time frame: 4 weeks
Population: Data for 63 participant were available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Insomnia Severity Index (Subjective Sleep Quality) | 7.8 units on a scale | Standard Error 0.8 |
| SensAwake Off | Insomnia Severity Index (Subjective Sleep Quality) | 7.3 units on a scale | Standard Error 0.7 |
Secondary
OSA Impact of Daily Life
Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.
Time frame: 4 weeks
Population: Data for 62 participant were available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | OSA Impact of Daily Life | 32.7 units on a scale | Standard Error 1 |
| SensAwake Off | OSA Impact of Daily Life | 34.6 units on a scale | Standard Error 0.9 |
Secondary
OSA Impact of Daily Life (Fatigue)
Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.
Time frame: 4 weeks
Population: Data for 64 participant were available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | OSA Impact of Daily Life (Fatigue) | 29.3 units on a scale | Standard Error 1.6 |
| SensAwake Off | OSA Impact of Daily Life (Fatigue) | 28.2 units on a scale | Standard Error 1.9 |
Secondary
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change
Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.
Time frame: 4 weeks
Population: Data for 64 participant were available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change | 4.2 units on a scale | Standard Error 0.2 |
| SensAwake Off | Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change | 4.3 units on a scale | Standard Error 0.2 |
Secondary
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity
Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.
Time frame: 4 weeks
Population: Data for 64 participant were available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity | 4.3 units on a scale | Standard Error 0.2 |
| SensAwake Off | Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity | 4.4 units on a scale | Standard Error 0.2 |
Post Hoc
Adherence in Patients With Signs of Moderate Clinical Insomnia
Adherence from the device (during their first treatment arm) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)
Time frame: 4 weeks
Population: Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Adherence in Patients With Signs of Moderate Clinical Insomnia | 322.89 minutes | Standard Error 26.46 |
| SensAwake Off | Adherence in Patients With Signs of Moderate Clinical Insomnia | 282.25 minutes | Standard Error 30.58 |
Post Hoc
Adherence in Patients With Signs of Moderate Clinical Insomnia
Adherence from the device (during their entire study period) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)
Time frame: 8 weeks
Population: Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Adherence in Patients With Signs of Moderate Clinical Insomnia | 304.787 minutes | Standard Error 28.75 |
| SensAwake Off | Adherence in Patients With Signs of Moderate Clinical Insomnia | 238.42 minutes | Standard Error 35.57 |
Other Pre-specified
Apnea Hypopnea Index (AHI)
Collected through the device
Time frame: 2 weeks
Population: Only 61 participant data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Apnea Hypopnea Index (AHI) | 5.182 events/hour | Standard Error 0.59 |
| SensAwake Off | Apnea Hypopnea Index (AHI) | 3.563 events/hour | Standard Error 0.464 |
Other Pre-specified
Leak
The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device
Time frame: One night
Population: Obtained only 61 participant CPAP data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SensAwake On | Leak | 41.72 L/min | Standard Error 2.52 |
| SensAwake Off | Leak | 48.91 L/min | Standard Error 3.01 |