Obstructive Sleep Apnea
Conditions
Brief summary
Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
Detailed description
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.
Interventions
DEVICEAuto AFlex
Positive pressure therapy treatment
DEVICEAuto CPAP
Positive pressure therapy treatment
DEVICECPAP
Positive pressure therapy treatment
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21 - 75 * Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep * Able and willing to provide written informed consent * Agreement to try PAP (positive airway pressure) as initial treatment approach * Adequate clinical CPAP titration within two weeks of enrollment
Exclusion criteria
* Participation in another interventional research study within the last 30 days * The need for more than one titration PSG (polysomnography) * The use of sedatives or hypnotics during the titration PSG * Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment. * Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.) * Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation \< or equal to 88% for more than five minutes). * Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days * Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP) * Presence of untreated or poorly managed, non-OSAHS related sleep disorders: * moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals) * Restless Leg syndrome (greater than 10 per hour) * Males experiencing chronic insomnia * Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week. * Consumption of ethanol more than 4 nights per week (CAGE criteria) * Shift workers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index | Baseline and 180 Days | The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor Vigilance Task - Number of Lapses | Baseline and 180 Days | Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses. Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms. |
| Functional Outcomes of Sleep Questionnaire (FOSQ) | Baseline and 180 Days | FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions). Scores are provided on a 0 to 4 scale: 0- I don't do this activity for other reasons or missing response 1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired. |
| Average Hours of Nightly Use. | 180 days | The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study. |
| Subjective Assessment of Therapy Comfort. | 30, 90, and 180 days | visual analog scales where used to assess the question in the last month how do you rate the overall comfort of the mask? 0 = very uncomfortable to 100 = very comfortable |
| Epworth Sleepiness Scale | Baseline and 180 days | Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey. Scores are provided on a 0 to 3 scale: 0 = no chance of dozing 1. = slight chance of dozing 2. = moderate chance of dozing 3. = high chance of dozing Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness. |
| Attitudes Toward Use | Baseline and 180 Days | Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance. Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident. Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective. |
Countries
Germany, United States
Participant flow
Recruitment details
Patients who completed routine clinical diagnostic visit and CPAP titration polysomnography (PSG) at 5 international sleep centers were consecutively recruited for the study. These patients were approached with information on the study and were asked to consent to participate.
Pre-assignment details
168 participants were enrolled into the study. However 4 participants were excluded from the analysis and demographic data because they withdrew from the trial prior to any study procedures.
Participants by arm
| Arm | Count |
|---|---|
| Auto Aflex auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment | 54 |
| Auto CPAP auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment | 53 |
| CPAP continuous positive airway pressure
CPAP: Positive pressure therapy treatment | 57 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 6 | 10 |
Baseline characteristics
| Characteristic | Auto Aflex | Total | CPAP | Auto CPAP |
|---|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 11.6 | 48.9 years STANDARD_DEVIATION 11.2 | 48.8 years STANDARD_DEVIATION 12 | 48.3 years STANDARD_DEVIATION 10 |
| Apnea-Hypopnea Index | 36.87 events/hour STANDARD_DEVIATION 30 | 38.52 events/hour STANDARD_DEVIATION 30.6 | 41.08 events/hour STANDARD_DEVIATION 31.57 | 37.29 events/hour STANDARD_DEVIATION 31.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 19 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 46 Participants | 135 Participants | 47 Participants | 42 Participants |
| Region of Enrollment Germany | 15 participants | 36 participants | 12 participants | 9 participants |
| Region of Enrollment United States | 39 participants | 128 participants | 45 participants | 44 participants |
| Sex: Female, Male Female | 13 Participants | 40 Participants | 14 Participants | 13 Participants |
| Sex: Female, Male Male | 41 Participants | 124 Participants | 43 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 53 | 0 / 57 |
| serious Total, serious adverse events | 0 / 54 | 0 / 53 | 0 / 57 |
Outcome results
Primary
Apnea-Hypopnea Index
The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days
Time frame: Baseline and 180 Days
Population: During the course of the study 24 participants withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auto Aflex | Apnea-Hypopnea Index | Baseline | 6.09 events/hour | Standard Deviation 7.2 |
| Auto Aflex | Apnea-Hypopnea Index | 180 Days | 1.26 events/hour | Standard Deviation 2.92 |
| Auto CPAP | Apnea-Hypopnea Index | 180 Days | 0.67 events/hour | Standard Deviation 0.93 |
| Auto CPAP | Apnea-Hypopnea Index | Baseline | 3.54 events/hour | Standard Deviation 4.39 |
| CPAP | Apnea-Hypopnea Index | 180 Days | 1.04 events/hour | Standard Deviation 1.28 |
| CPAP | Apnea-Hypopnea Index | Baseline | 3.24 events/hour | Standard Deviation 3.46 |
p-value: 0.3Kruskal-Wallis
Secondary
Attitudes Toward Use
Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance. Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident. Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective.
Time frame: Baseline and 180 Days
Population: During the course of the study 24 participants withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auto Aflex | Attitudes Toward Use | Confidence at baseline | 20.7 units on a scale | Standard Deviation 3.6 |
| Auto Aflex | Attitudes Toward Use | Confidence at 180 days | 20.7 units on a scale | Standard Deviation 5.2 |
| Auto Aflex | Attitudes Toward Use | Expectations + Importance at baseline | 49.8 units on a scale | Standard Deviation 7.4 |
| Auto Aflex | Attitudes Toward Use | Expectations + Importance at 180 days | 47.2 units on a scale | Standard Deviation 5.3 |
| Auto CPAP | Attitudes Toward Use | Confidence at 180 days | 22.5 units on a scale | Standard Deviation 3.3 |
| Auto CPAP | Attitudes Toward Use | Expectations + Importance at 180 days | 46.7 units on a scale | Standard Deviation 5.8 |
| Auto CPAP | Attitudes Toward Use | Confidence at baseline | 21.8 units on a scale | Standard Deviation 2.9 |
| Auto CPAP | Attitudes Toward Use | Expectations + Importance at baseline | 48.4 units on a scale | Standard Deviation 5 |
| CPAP | Attitudes Toward Use | Confidence at baseline | 22.3 units on a scale | Standard Deviation 2.6 |
| CPAP | Attitudes Toward Use | Expectations + Importance at baseline | 48.1 units on a scale | Standard Deviation 6.9 |
| CPAP | Attitudes Toward Use | Confidence at 180 days | 21.9 units on a scale | Standard Deviation 4.1 |
| CPAP | Attitudes Toward Use | Expectations + Importance at 180 days | 46.9 units on a scale | Standard Deviation 5 |
Secondary
Average Hours of Nightly Use.
The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study.
Time frame: 180 days
Population: During the course of the study 24 participants withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Aflex | Average Hours of Nightly Use. | 4.44 hours | Standard Deviation 1.98 |
| Auto CPAP | Average Hours of Nightly Use. | 4.63 hours | Standard Deviation 1.75 |
| CPAP | Average Hours of Nightly Use. | 4.40 hours | Standard Deviation 2.02 |
Secondary
Epworth Sleepiness Scale
Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey. Scores are provided on a 0 to 3 scale: 0 = no chance of dozing 1. = slight chance of dozing 2. = moderate chance of dozing 3. = high chance of dozing Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness.
Time frame: Baseline and 180 days
Population: During the course of the study 24 participants withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auto Aflex | Epworth Sleepiness Scale | Baseline | 10.43 units on a scale | Standard Deviation 5.25 |
| Auto Aflex | Epworth Sleepiness Scale | 180 Days | 6.93 units on a scale | Standard Deviation 4.3 |
| Auto CPAP | Epworth Sleepiness Scale | Baseline | 10.49 units on a scale | Standard Deviation 4.59 |
| Auto CPAP | Epworth Sleepiness Scale | 180 Days | 7.02 units on a scale | Standard Deviation 4.66 |
| CPAP | Epworth Sleepiness Scale | Baseline | 12.27 units on a scale | Standard Deviation 5.94 |
| CPAP | Epworth Sleepiness Scale | 180 Days | 7.87 units on a scale | Standard Deviation 5.53 |
Secondary
Functional Outcomes of Sleep Questionnaire (FOSQ)
FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions). Scores are provided on a 0 to 4 scale: 0- I don't do this activity for other reasons or missing response 1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired.
Time frame: Baseline and 180 Days
Population: During the course of the study 24 participants withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auto Aflex | Functional Outcomes of Sleep Questionnaire (FOSQ) | baseline | 15.17 score on a scale | Standard Deviation 3.13 |
| Auto Aflex | Functional Outcomes of Sleep Questionnaire (FOSQ) | 180 days | 17.11 score on a scale | Standard Deviation 2.22 |
| Auto CPAP | Functional Outcomes of Sleep Questionnaire (FOSQ) | baseline | 15.85 score on a scale | Standard Deviation 2.94 |
| Auto CPAP | Functional Outcomes of Sleep Questionnaire (FOSQ) | 180 days | 17.78 score on a scale | Standard Deviation 2.06 |
| CPAP | Functional Outcomes of Sleep Questionnaire (FOSQ) | 180 days | 16.74 score on a scale | Standard Deviation 3.26 |
| CPAP | Functional Outcomes of Sleep Questionnaire (FOSQ) | baseline | 14.57 score on a scale | Standard Deviation 3.97 |
Secondary
Psychomotor Vigilance Task - Number of Lapses
Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses. Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms.
Time frame: Baseline and 180 Days
Population: During the course of the study 24 participants withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auto Aflex | Psychomotor Vigilance Task - Number of Lapses | Baseline | 2.15 number of lapses | Standard Deviation 3.74 |
| Auto Aflex | Psychomotor Vigilance Task - Number of Lapses | 180 days | 0.98 number of lapses | Standard Deviation 2.14 |
| Auto CPAP | Psychomotor Vigilance Task - Number of Lapses | Baseline | 3.41 number of lapses | Standard Deviation 7.75 |
| Auto CPAP | Psychomotor Vigilance Task - Number of Lapses | 180 days | 0.96 number of lapses | Standard Deviation 1.32 |
| CPAP | Psychomotor Vigilance Task - Number of Lapses | 180 days | 1.30 number of lapses | Standard Deviation 3.32 |
| CPAP | Psychomotor Vigilance Task - Number of Lapses | Baseline | 2.15 number of lapses | Standard Deviation 4.1 |
Secondary
Subjective Assessment of Therapy Comfort.
visual analog scales where used to assess the question in the last month how do you rate the overall comfort of the mask? 0 = very uncomfortable to 100 = very comfortable
Time frame: 30, 90, and 180 days
Population: During the course of the study 24 participants withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auto Aflex | Subjective Assessment of Therapy Comfort. | 90 days | 53.8 units on a scale | Standard Deviation 25.1 |
| Auto Aflex | Subjective Assessment of Therapy Comfort. | 30 days | 50.8 units on a scale | Standard Deviation 21.5 |
| Auto Aflex | Subjective Assessment of Therapy Comfort. | 180 days | 54.7 units on a scale | Standard Deviation 21.7 |
| Auto CPAP | Subjective Assessment of Therapy Comfort. | 90 days | 61.0 units on a scale | Standard Deviation 15 |
| Auto CPAP | Subjective Assessment of Therapy Comfort. | 30 days | 57.9 units on a scale | Standard Deviation 20.5 |
| Auto CPAP | Subjective Assessment of Therapy Comfort. | 180 days | 60.1 units on a scale | Standard Deviation 14.7 |
| CPAP | Subjective Assessment of Therapy Comfort. | 30 days | 53.9 units on a scale | Standard Deviation 18.9 |
| CPAP | Subjective Assessment of Therapy Comfort. | 180 days | 60.6 units on a scale | Standard Deviation 17.9 |
| CPAP | Subjective Assessment of Therapy Comfort. | 90 days | 59.2 units on a scale | Standard Deviation 18.3 |