Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
Positive pressure therapy treatment
Positive pressure therapy treatment
Positive pressure therapy treatment
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Stanford University
Stanford, California, United States
Gaylord Hospital
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
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
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
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
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.
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Charite Universitatsmedizin Berlin
Berlin, Germany
Time frame: Baseline and 180 Days
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
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
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