Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | REMStar auto A-Flex |
|
| Group 2 | Experimental | modified REMstar Auto A-Flex with AGPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMstar Auto A-Flex | Device | Standard CPAP |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| CPAP Adherence | Device usage (hours per night) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan Lankford, PhD | Sleep Disorders Center of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delta Waves Sleep Disorder and Research Center | Colorado Springs | Colorado | 80918 | United States | ||
| Sleep Disorders Center of Georgia |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP |
| FG001 | Group 2 | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| modified REMstar Auto A-Flex with AGPAP | Device | Modified device -Software upgrade to GP 12 |
|
|
| 3 months |
| 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'. | 3 months |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| Clinilabs, Inc. | New York | New York | 10019 | United States |
| Sleep Therapy and Research Center | San Antonio | Texas | 78229 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
241 participants were enrolled in the trial and randomized, 123 in group 1 and 118 in group 2. 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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP |
| BG001 | Group 2 | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Apnea-hypopnea index (AHI) | Mean | Standard Deviation | events/hour |
| |||||||||||||||
| CPAP Prescription | Mean | Standard Deviation | cmH2O |
| |||||||||||||||
| Functional Outcomes Sleep Questionnaire (FOSQ) (quality of life questionnaire | 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). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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'. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CPAP Adherence | Device usage (hours per night) | 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. | Posted | Mean | Standard Deviation | hours per night | 3 months |
|
|
| ||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
| ||||||||||||||||||||||||||||||
| 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'. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
Adverse events were collected during the device trial period, e.g. 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1- Standard CPAP | REMStar auto A-Flex REMstar Auto A-Flex: Standard CPAP | 0 | 120 | 2 | 120 | 30 | 120 |
| EG001 | Group 2 -AGPAP | modified REMstar Auto A-Flex with AGPAP modified REMstar Auto A-Flex with AGPAP: Modified device -Software upgrade to GP 12 | 0 | 115 | 1 | 115 | 33 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Hospitalization | Cardiac disorders | Systematic Assessment | Participant 404 was hospitalized with complaints of dizziness and light-headed. The report obtained from the Hospital lists subconjunctival hemorrhage, severe uncontrolled hypertension, and uncontrolled diabetes as the main findings |
| |
| Bipolar manic episode | Product Issues | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | General disorders | Systematic Assessment |
| ||
| Aerophagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cold/flu symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchites/asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hand fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Broken & casted R carpal, 5th digit |
| |
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Ankle swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Upset stomach and diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| cracked dental implant | General disorders | Systematic Assessment |
| ||
| Dry, Stuffy Nose or Nosebleeds, skin irritation | Reproductive system and breast disorders | Systematic Assessment | These are common side effects of CPAP therapy. https://www.sleepassociation.org/sleep-apnea/cpap-treatment/cpap-side-effects/ |
| |
| Worsening of hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| MRSA in armpit | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Data Scientist | Philips | +14125423651 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|