Obstructive Sleep Apnea
Conditions
Brief summary
Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extended duration ramp, where the patient receives pressure below their prescription during an acclimation phase. The algorithm gradually increases pressure to therapy level based on usage. The aim of this study was to determine the effectiveness of the AGPAP acclimation period and its impact on short term adherence.
Detailed description
Even though CPAP is highly effective in treating sleep apnea, adherence to CPAP therapy remains the largest single obstacle to the successful resolution of sleep-disordered breathing in OSA patients. It has been estimated that up to 50% of patients who have been prescribed CPAP for Obstructive Sleep Apnea (OSA) are not using the treatment one year later. A myriad of possible causes for low compliance rates have been proposed and examined in previous studies. These include race, gender, education level, income, bed-partner's sleep quality, mask discomfort, continuity of care, nasal irritation, discomfort due to elevated expiratory pressure, and level of daytime sleepiness. Therefore, many investigators have proposed new methods and approaches to help deal with these problems. Interventions have ranged from people-centric approaches using intensive CPAP education and follow-up programs, to device modifications using features such as a ramp, C-FLEX®, BiLevel therapy, and heated humidification. In this study. The aim of this study was to determine the effectiveness of the Automated Graduated CPAP (AGPAP), also know as EZ-start acclimation period, and its impact on short term adherence
Interventions
DEVICEREMstar Auto A-Flex
Standard CPAP
DEVICEmodified REMstar Auto A-Flex with AGPAP
Modified device -Software upgrade to GP 12
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed with OSA (last 12 weeks) * Prescribed continuous positive airway pressure (CPAP) pressure ≥ 10 cmH2O * Willing and able to provide informed consent * Able to follow instructions
Exclusion criteria
* Participation in another interventional research study within the last 30 days * Major controlled or an uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.) * Prior PAP prescription, use, or any prior OSA treatment, excluding split-night or titration PAP exposure. * Prescribed BiLevel therapy * Presence of untreated, non-OSA related sleep disorders (e.g. moderate to severe restless legs (PLMAI ≥ 20) or insomnia) * History of an automobile accident or near accident in the last 12 months due to sleepiness. * Severe oxygen desaturation on the PSG (Sa02 \< 70% for 10% of the diagnostic PSG study). * Surgery of the upper airway, nose, sinus, or middle ear within the past 90 days * Regular use (\>3 nights per week) of sleeping pills or stimulants. * Currently working a night shift or rotating day/night shift. * Unwillingness to try PAP at home. * Presence of tracheostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP Adherence | 3 months | Device usage (hours per night) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome Sleep Quality (FOSQ) | 3 months | Functional Outcomes Sleep Questionnaire (FOSQ) is a self-administered instrument designed to assess the impact of excessive sleepiness on daytime function and to quantify improvement after treatment. It contains 30 items divided into 5 subscales: Activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcome. The patient rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty) A mean score is calculated for each scale ranging from 0 (maximum functional impact) to 24 (no functional impact). |
| Daytime Sleepiness as Measured by the Epworth Sleepiness Scale | 3 months | Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score can range from 0 to 24. The higher the ESS score, the higher is the overall 'daytime sleepiness'. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 REMStar auto A-Flex
REMstar Auto A-Flex: Standard CPAP | 120 |
| Group 2 modified REMstar Auto A-Flex with AGPAP
modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 | 115 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | protocol deviation | 3 | 23 |
| Overall Study | Withdrawal by Subject | 19 | 13 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 10.5 | 46.2 years STANDARD_DEVIATION 11 | 47.3 years STANDARD_DEVIATION 10.8 |
| Apnea-hypopnea index (AHI) | 44.6 events/hour STANDARD_DEVIATION 34.6 | 42.2 events/hour STANDARD_DEVIATION 31.1 | 43.4 events/hour STANDARD_DEVIATION 32.9 |
| CPAP Prescription | 12.1 cmH2O STANDARD_DEVIATION 2.1 | 12.3 cmH2O STANDARD_DEVIATION 2.2 | 12.2 cmH2O STANDARD_DEVIATION 2.2 |
| Epworth Sleepiness Scale | 12.2 units on a scale STANDARD_DEVIATION 4.6 | 11.6 units on a scale STANDARD_DEVIATION 5.1 | 11.9 units on a scale STANDARD_DEVIATION 4.9 |
| Functional Outcomes Sleep Questionnaire (FOSQ) (quality of life questionnaire | 2.9 units on a scale STANDARD_DEVIATION 0.6 | 2.8 units on a scale STANDARD_DEVIATION 0.7 | 2.8 units on a scale STANDARD_DEVIATION 0.6 |
| Region of Enrollment United States | 120 Participants | 115 Participants | 235 Participants |
| Sex: Female, Male Female | 49 Participants | 42 Participants | 91 Participants |
| Sex: Female, Male Male | 71 Participants | 73 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 115 |
| other Total, other adverse events | 30 / 120 | 33 / 115 |
| serious Total, serious adverse events | 2 / 120 | 1 / 115 |
Outcome results
Primary
CPAP Adherence
Device usage (hours per night)
Time frame: 3 months
Population: 241 participants were enrolled in the trial and randomized, group 1 = 123 and group 2 = 118. There were 3 protocol deviations in group 1 and 23 deviations in group 2. Data from these participants were excluded from the final analysis as per the statistical plan, and an intention to treat analysis was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | CPAP Adherence | 3.6 hours per night | Standard Deviation 2.5 |
| Group 2 | CPAP Adherence | 4.0 hours per night | Standard Deviation 2.3 |
Secondary
Daytime Sleepiness as Measured by the Epworth Sleepiness Scale
Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score can range from 0 to 24. The higher the ESS score, the higher is the overall 'daytime sleepiness'.
Time frame: 3 months
Population: 241 participants were enrolled in the trial and randomized, group 1 = 123 and group 2 = 118. There were 3 protocol deviations in group 1 and 23 deviations in group 2. Data from these participants were excluded from the final analysis as per the statistical plan, and an intention to treat analysis was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Daytime Sleepiness as Measured by the Epworth Sleepiness Scale | 8.05 units on a scale | Standard Deviation 4.45 |
| Group 2 | Daytime Sleepiness as Measured by the Epworth Sleepiness Scale | 8.27 units on a scale | Standard Deviation 4.8 |
Secondary
Functional Outcome Sleep Quality (FOSQ)
Functional Outcomes Sleep Questionnaire (FOSQ) is a self-administered instrument designed to assess the impact of excessive sleepiness on daytime function and to quantify improvement after treatment. It contains 30 items divided into 5 subscales: Activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcome. The patient rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty) A mean score is calculated for each scale ranging from 0 (maximum functional impact) to 24 (no functional impact).
Time frame: 3 months
Population: 241 participants were enrolled in the trial and randomized, group 1 = 123 and group 2 = 118. There were 3 protocol deviations in group 1 and 23 deviations in group 2. Data from these participants were excluded from the final analysis as per the statistical plan, and an intention to treat analysis was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Functional Outcome Sleep Quality (FOSQ) | 3.35 units on a scale | Standard Deviation 0.68 |
| Group 2 | Functional Outcome Sleep Quality (FOSQ) | 3.25 units on a scale | Standard Deviation 0.64 |