An interventional study of Standard of Care and Personalized OSA Treatment in Sleep Apnea, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of Miami · Not applicable, Interventional, and Health services research
Among 369 studies in Sleep Apnea Syndromes with a site in United States — 49 open to participants now, 60 under way, 3 of them phase 3. Sleep Apnea Syndromes · United States.
Among the 369 studies in Sleep Apnea Syndromes with a site in United States, this one is the 23rd largest by planned enrollment of the 284 interventional ones, is one of 14 that started in 2024, is one of 193 with no phase, reaches primary completion later than 36 of the 59 other live ones, and was the 324th registered.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's planned enrollment of 330 is above the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →49 of the 369 studies in Sleep Apnea Syndromes with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 117 Sleep Apnea Syndromes studies recruiting now, 57 (49%) set no upper age limit and 36 (31%) stop at 75 or younger; 24 take children under 18; 27 take healthy volunteers.
This study: 55 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →369 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 14 started in 2024.
Median enrollment 62 across the 284 interventional studies, 114 across the 82 observational. Of the 268 that completed or were terminated, 134 (50%) have results posted.
82 of 369 have an industry lead sponsor. The 10 most frequent:
University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
University of Miami has 3 studies filed under Sleep Apnea Syndromes — fewer than ten, so there is no comparison to draw.
29 of the studies in Sleep Apnea Syndromes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05382754Children's Hospital of PhiladelphiaHome Apnea Testing in CHildren Trial | 2026-12 |
| NCT05575401Loma Linda UniversityLateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy | 2026-12 |
| NCT02431507Michael HarrisonMagnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety | 2026-12-01 |
| NCT07908199Ouraring Inc.Oura Ring OA15 Validation | 2026-12-03 |
| NCT03278119NYU Langone HealthSleep Aging and Risk for Alzheimer's 2.0 | 2026-12-25 |
Among the 369 studies in Sleep Apnea Syndromes with a site in United States, from their registry updates:
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).
The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this group receive the standard of care treatment for sleep apnea for up to six months.
Other: Standard of Care
Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.
Other: Standard of Care · Behavioral: Personalized OSA Treatment
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.
Proportion of participants adherence to OSA treatment
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: 6 months.
Change in Molecular and Inflammatory Biomarkers measured in mg/dl
Molecular biomarkers assessed include C₂N, homocysteine, neurofilament light (NfL), glial fibrillary acidic protein (GFAP), tau, and amyloid-beta peptides, along with inflammatory cytokines interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-α). All biomarkers will be measured in picograms per milliliter from blood samples collected at each assessment time point. Higher values indicate greater circulating concentrations of the respective biomarker.
Time frame: Baseline and 6 months
Change in Vascular Markers
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
Change in Cardiometabolic Biomarkers as measured in mg/dl
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
Change in Cardiometabolic Biomarkers as measured in grams per deciliter
Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses.
Time frame: Baseline and 6 months
Change in Cardiometabolic Biomarkers as measured in mmol/mol
Glucose/HbA1C, Chloride, Potassium, Sodium, Homocysteine. Measured in mmol/mol assessed with blood analyses
Time frame: Baseline and 6 months
Change in Cardiometabolic Biomarkers- platelet count
Platelet Count. Measured per microliter of Blood.
Time frame: Baseline and 6 months
Change in Cardiometabolic Biomarkers as measured per microliter of Blood.
Blood Pressure. Measured per microliter of Blood.
Time frame: Baseline and 6 months
Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.
Thyroid-stimulating hormone. Measured in milli-international units per litre.
Time frame: Baseline and 6 months
Change in Cardiometabolic Biomarkers as measured milligrams per liter
C-reactive protein Highly Sensitive. Measured milligrams per liter.
Time frame: Baseline and 6 months
Change in Cardiometabolic Biomarkers Measured in microgram
Folate. Measured microgram.
Time frame: Baseline and 6 months
Change in Cardiometabolic Biomarkers Measured picograms per milliliter
Vitamin B12. Measured picograms per milliliter.
Time frame: Baseline and 6 months
Change in NIH Toolbox -Oral Reading Recognition Test
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. Performance will be reported using the NIH Toolbox standardized score. Higher scores indicate better reading decoding and crystallized cognitive ability. Standard scores are norm-referenced, with a mean of 100 and standard deviation of 15. The test also contributes to the NIH Toolbox Crystallized Cognition Composite.
Time frame: Baseline and 6 months
Change in NIH Toolbox -Picture Vocabulary Test
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. Performance will be reported using the NIH Toolbox standardized score, with higher scores indicating better receptive vocabulary and crystallized cognitive ability. Standard scores are norm-referenced, with a mean of 100 and standard deviation of 15. The test also contributes to the NIH Toolbox Crystallized Cognition Composite.
Time frame: Baseline and 6 months
Change in NIH Toolbox -Flanker Inhibitory Control and Attention
An assessment of inhibitory control and attention. Participants will be asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it. This outcome will be reported as a composite score. Performance will be reported using the NIH Toolbox standardized score, which incorporates accuracy and reaction time. Higher scores indicate better inhibitory control and attention. This measure contributes to the NIH Toolbox Fluid Cognition Composite.
Time frame: Baseline and 6 months
Change in Executive Function measured by Dimensional Change Card Sort Test
Executive function. An assessment of cognitive flexibility and attention. Participants will be asked to match a series of picture pairs to a target picture. Performance will be reported using the NIH Toolbox standardized score, which incorporates accuracy and reaction time. Higher scores indicate better cognitive flexibility and executive functioning. This measure contributes to the NIH Toolbox Fluid Cognition Composite.
Time frame: Baseline and 6 months
Change in Episodic memory measured by Picture Sequence Memory Test
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. Performance will be reported using the NIH Toolbox standardized score, with higher scores indicating better episodic memory performance. This measure contributes to the NIH Toolbox Fluid Cognition Composite.
Time frame: Baseline and 6 months
Change in NIH Toolbox- Auditory Verbal Learning Test
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. Performance will be reported as the number of words correctly recalled, including immediate learning/recall across the three trials and delayed recall. Higher scores indicate better verbal learning and memory.
Time frame: Baseline and 6 months
Change in Working Memory measured by List Sorting Task
An assessment of working memory. Participants will be asked to recall and sequence different stimuli that are presented visually and via audio. Performance will be reported using the NIH Toolbox standardized score, with higher scores indicating better working memory performance.
Time frame: Baseline and 6 months
Change in Processing Speed measured by Pattern Comparison Processing Speed Test
An assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. Performance will be reported using the NIH Toolbox standardized score, with higher scores indicating faster and better processing-speed performance. This measure contributes to the NIH Toolbox Fluid Cognition Composite.
Time frame: Baseline and 6 months
Change in Working Memory measured by Number Span Subset
In this test, participants will be 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 and 6 months
Change in Health-related quality of life
Health-related quality of life will be assessed using the 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 indicate better self-reported health-related quality of life
Time frame: Baseline, 2 months, and 6 months
Change in Daytime functioning
Change in Daytime functioning will be assessed using the 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, and 6 months
Change in Sleep Quality measured by Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance
Change in Sleep Quality will be assessed using the 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). Item responses are summed up to produce a raw score ranging from 4 to 20 and converted into a standardized PROMIS T-score. The T-score metric has a population mean of 50 and standard deviation of 10. Higher scores indicate greater sleep disturbance/poorer perceived sleep quality, while lower scores indicate less sleep disturbance/better perceived sleep quality. For this form, raw scores of 4-20 correspond to T-scores of approximately 32.0-73.3.
Time frame: Baseline, 2 months, and 6 months
Change in number of minutes as measured by FitBit
Sleep quality will be measured by the number of minutes by FitBit Sleep Stages.
Time frame: Baseline, 2 months, and 6 months
Change in Sleep quality measured by Sleep Score
Sleep quality as assessed by the Fitbit Sleep Score. Scores range from 1 to 100, with higher scores indicating better sleep quality. Sleep Score categories are interpreted as follows: Excellent (90-100), Good (80-89), Fair (60-79), and Poor (\<60).
Time frame: Baseline, 2 months, and 6 months
Change in Cardiometabolic Biomarkers as measured in percentage
Hematocrit is the percentage of whole blood volume occupied by red blood cells and will be measured from a blood sample. Measured as a percentage.
Time frame: Baseline, 2 months, and 6 months
Change in number of calories burned
Number of calories burned measured by FitBit
Time frame: Baseline, 2 months, and 6 months
Change in the number of floors climbed
Number of floors climbed measured by Fitbit
Time frame: Baseline, 2 months, and 6 months
Change in the distance traveled
Distance traveled measured in Miles by Fitbit
Time frame: Baseline, 2 months, and 6 months
Change in number of steps taken
Number of steps taken measured by Fitbit
Time frame: Baseline, 2 months, and 6 months
Change in sleep awakening
Sleep Awakening measured (Insert how it will be reported) by Fitbit. The outcome will be reported as the number of minutes spent awake during the nightly sleep period, as recorded by Fitbit. Nightly values will be collected during the Fitbit monitoring period, with higher values indicating more time awake during the sleep period and greater sleep disruption. Fitbit records time in minutes spent awake, REM, deep sleep, and light sleep, as well as a nightly sleep score from 0-100.
Time frame: Baseline, 2 months, and 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Nov 2027, 44 months after the start.
Of 200 non-industry interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 60. This study's planned 44 months is close to that.
Counting every sponsor, half of 268 studies reached it within 26 months; a quarter within 11 and three quarters within 56.
Primary completion moved once since we started tracking on Sep 25, 2026: May 2027 → Nov 2027, on Oct 20, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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