University of Miami
Miami, Florida, 33136, United States
Location status: Recruiting
NCT Number: NCT06089161
The purpose of this research is to see how effective the Personalized obstructive sleep apnea (OSA) Treatment Adherence Model called PRAISE is in helping the patient stick to the physician recommended OSA treatment plan Positive Airway Pressure (PAP).
Interested in participating?
Request Info60 year–85 year
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this group will receive standard of care treatment for sleep apnea.
Participants in this group will receive standard of care treatment plus the personalized treatment that consists of videos approximately three minutes long, virtual, accessed through web based application, that the participant watches weekly. The purpose of the video is tailored educational content for sleep apnea.
Time frame: Up to 6 months
The proportion of participants who answer yes (meaning a participant acknowledges an average of more than 4 hours of continuous positive airway pressure use) or no (meaning a participant acknowledges an average of less than 4 hours of continuous positive airway pressure use).
Time frame: Baseline and 6 months
The molecular biomarker are C₂N, Homocysteine, Neurofilament light, Glial fibrillary acidic protein, Tau, and Amyloid-Beta peptides and the inflammatory markers are Interleukin-6,Interleukin -10, and Tumor Necrosis Factor-alpha. All will be measured in picograms per milliliter.
Time frame: Baseline and 6 months
Red Blood Cell Count, White Blood Cell Count, and Platelet Count will be measured. All will be measured in Cells/L.
Time frame: Baseline and 6 months
Total Cholesterol, HDL, LDL, Triglycerides, Bilirubin, Blood Urea Nitrogen (BUN), Calcium, Creatinine, and Glucose. Measured in milligrams/deciliter (mg/dl) assessed with blood analyses.
Time frame: Baseline and 6 months
Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses.
Time frame: Baseline and 6 months
Glucose/HbA1C, Chloride, Potassium, Sodium, Homocysteine. Measured in mmol/mol assessed with blood analyses
Time frame: Baseline and 6 months
Platelet Count. Measured per microliter of Blood.
Time frame: Baseline and 6 months
Blood Pressure. Measured per microliter of Blood.
Time frame: Baseline and 6 months
Thyroid-stimulating hormone. Measured Milli-international units per litre.
Time frame: Baseline and 6 months
C-reactive protein Highly Sensitive. Measure milligrams per liter.
Time frame: Baseline and 6 months
Folate. Measured microgram.
Time frame: Baseline and 6 months
Vitamin B12. Measured picograms per milliliter.
Time frame: Baseline, 6 months
An assessment of reading decoding skills and crystalized abilities. Participants are asked to read aloud letters and words, pronouncing the words as accurately as possible.
Time frame: Baseline, 6 months
An assessment of receptive vocabulary administered in a computer-adaptive test (CAT) format. Participants must choose which of four pictures best represents a word presented via audio.
Time frame: Baseline, 6 months
An assessment of inhibitory control and attention. The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it. This outcome will be reported as a composite score.
Time frame: Baseline, 6 months
Executive function, An assessment of cognitive flexibility and attention. The participant is asked to match a series of picture pairs to a target picture.
Time frame: Baseline, 6 months
Episodic memory, An assessment of episodic memory. Participants are shown a number of activities, and then asked to reproduce the sequence of pictures as it was presented.
Time frame: Baseline, 6 months
Participants are given three trials to recall as many words as possible from a list of fifteen unrelated words. After a 5-25 minute delay, participants are asked to freely recall as many of the 15 words as possible..
Time frame: Baseline, 6 months
Working memory, An assessment of working memory. The participant is asked to recall and sequence different stimuli that are presented visually and via audio.
Time frame: Baseline, 6 months
Processing speed, An assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same.
Time frame: Baseline, 6 months
In this test, the participant is asked to recall a series of numbers in reverse order. The correctly recalled series are scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.
Time frame: Baseline, 2 months, 6 months
Patient-Reported Outcomes Measurement Information System Short Form v1.1 - Global Health (5. Excellent, 4. Very good, 3. Good, 2. Fair, 1. Poor) Higher score indicates better self-reported health-related quality of life
Time frame: Baseline, 2 months, 6 months
Patient-Reported Outcomes Measurement Information System Short form v1.0 Sleep-Related Impairment 8a (1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much) A lower score indicates better daytime functioning
Time frame: Baseline, 2 months, 6 months
Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance 4a (1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much)
Time frame: Baseline, 2 months, 6 months
Sleep quality will be measured by the number of minutes by FitBit Sleep Stages.
Time frame: Baseline, 2 months, 6 months
FitBit Sleep score:
Excellent: 90 to 100 Good: 80 to 89 Fair: 60 to 79 Poor: less than 60 Min: 1 Max: 100 Excellent: 90-100 Good: 80-89 Fair: 60-79 Poor: Less than 60
Time frame: Baseline and 6 months
Hematocrit. Measured as a percentage.
Time frame: Baseline, 2 months, 6 months
Number of Calories burned
Time frame: Baseline, 2 months
Number of floors climbed
Time frame: Baseline, 2 months
distance traveled measured by mile
Time frame: Baseline, 2 months
number of steps taken
Time frame: Baseline, 2 months
Number of awakenings
Contact information is provided by the study sponsor or research team.
University of Miami
Other
Acronym: PRAISE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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