Sleep ApneaPRAISENCT06089161
Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
A study testing Personalized OSA Treatment in people with Sleep Apnea, run by University of Miami at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Personalized OSA Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 31 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported race/ethnicity as African American, African, Afro-latino, Caribbean or black
- Ages 55-85 years
- accessible by phone
- OSA diagnosis
- consent, including permission to release medical data
Who cannot join
- progressive illnesses in which disability or death is expected within 1 year
- impaired cognitive/ functional ability precluding participation
- intention to move within the year
- and a family member currently enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Girardin Jean-Louis, PhD, 3052430776, girardin.jean-louis@miami.edu
About this study
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).
- Conditions
- Sleep Apnea
- Being tested
- Standard of Care, Personalized OSA Treatment
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Participants in this group will receive standard of care treatment for sleep apnea.
Personalized OSA TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Active comparator | Participants in this group receive the standard of care treatment for sleep apnea for up to six months. Receives: Other: Standard of Care |
| Personalized OSA Treatment Group | Experimental | Participants in this group receive personalized OSA treatment for sleep apnea for up to six months. Receives: Other: Standard of Care; Behavioral: Personalized OSA Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months.
Secondary outcomes (31)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and 6 months
Change in Cardiometabolic Biomarkers- platelet count
Platelet Count. Measured per microliter of Blood.
Measured: Baseline and 6 months
Change in Cardiometabolic Biomarkers as measured per microliter of Blood.
Blood Pressure. Measured per microliter of Blood.
Measured: 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.
Measured: Baseline and 6 months
Change in Cardiometabolic Biomarkers as measured milligrams per liter
C-reactive protein Highly Sensitive. Measured milligrams per liter.
Measured: Baseline and 6 months
Change in Cardiometabolic Biomarkers Measured in microgram
Folate. Measured microgram.
Measured: Baseline and 6 months
Change in Cardiometabolic Biomarkers Measured picograms per milliliter
Vitamin B12. Measured picograms per milliliter.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 2 months, and 6 months
Change in number of calories burned
Number of calories burned measured by FitBit
Measured: Baseline, 2 months, and 6 months
Change in the number of floors climbed
Number of floors climbed measured by Fitbit
Measured: Baseline, 2 months, and 6 months
Change in the distance traveled
Distance traveled measured in Miles by Fitbit
Measured: Baseline, 2 months, and 6 months
Change in number of steps taken
Number of steps taken measured by Fitbit
Measured: 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.
Measured: Baseline, 2 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start19 Mar 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Girardin Jean-Louis, University of Miami
- Investigators
- Girardin Jean-Louis, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089161
- Sponsor's protocol ID
- 20220509
- Other IDs
- 5R01AG075007-04
- Acronym
- PRAISE
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No