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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.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
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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
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.

Girardin Jean-Louis, PhD contact

3052430776

girardin.jean-louis@miami.edu

United States1 site, 1 recruiting
  • University of Miami

    Miami, Florida, 33136

    Girardin Jean-Louis, PhD, 3052430776, girardin.jean-louis@miami.edu

    Recruiting

Other trials in United States

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 groups in NCT06089161
Study groupRoleWhat they receive
Standard of Care GroupActive comparatorParticipants 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 GroupExperimentalParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Change in Cardiometabolic Biomarkers- platelet count

    Platelet Count. Measured per microliter of Blood.

    Measured: Baseline and 6 months

  7. Change in Cardiometabolic Biomarkers as measured per microliter of Blood.

    Blood Pressure. Measured per microliter of Blood.

    Measured: Baseline and 6 months

  8. 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

  9. Change in Cardiometabolic Biomarkers as measured milligrams per liter

    C-reactive protein Highly Sensitive. Measured milligrams per liter.

    Measured: Baseline and 6 months

  10. Change in Cardiometabolic Biomarkers Measured in microgram

    Folate. Measured microgram.

    Measured: Baseline and 6 months

  11. Change in Cardiometabolic Biomarkers Measured picograms per milliliter

    Vitamin B12. Measured picograms per milliliter.

    Measured: Baseline and 6 months

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. Change in number of calories burned

    Number of calories burned measured by FitBit

    Measured: Baseline, 2 months, and 6 months

  28. Change in the number of floors climbed

    Number of floors climbed measured by Fitbit

    Measured: Baseline, 2 months, and 6 months

  29. Change in the distance traveled

    Distance traveled measured in Miles by Fitbit

    Measured: Baseline, 2 months, and 6 months

  30. Change in number of steps taken

    Number of steps taken measured by Fitbit

    Measured: Baseline, 2 months, and 6 months

  31. 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.

  1. First posted18 Oct 2023
  2. Study start19 Mar 2024
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

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)
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

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