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NCT Number: NCT06089161

Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks

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).

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Girardin Jean-Louis, PhD

CONTACT

[email protected]

3052430776

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-reported race/ethnicity as African American, African, Caribbean or black
  • Ages 60-85 years
  • accessible by phone
  • OSA diagnosis
  • consent, including permission to release medical data

Exclusion criteria

  • 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.

Treatment and study plan

Standard of care

Other

Participants in this group will receive standard of care treatment for sleep apnea.

Personalized OSA Treatment

Behavioral

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.

Primary outcomes

  1. Proportion of participants adherence to OSA treatment

    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).

Secondary outcomes

  1. Change in Molecular Biomarkers

    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.

  2. Change in Vascular Markers

    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.

  3. Change in Cardiometabolic Biomarkers measured in mg/dl

    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.

  4. Change in Cardiometabolic Biomarkers as measured in grams per deciliter

    Time frame: Baseline and 6 months

    Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses.

  5. Change in Cardiometabolic Biomarkers measured in mmol/mol

    Time frame: Baseline and 6 months

    Glucose/HbA1C, Chloride, Potassium, Sodium, Homocysteine. Measured in mmol/mol assessed with blood analyses

  6. Change in Cardiometabolic Biomarkers- platelet count

    Time frame: Baseline and 6 months

    Platelet Count. Measured per microliter of Blood.

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

    Time frame: Baseline and 6 months

    Blood Pressure. Measured per microliter of Blood.

  8. Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.

    Time frame: Baseline and 6 months

    Thyroid-stimulating hormone. Measured Milli-international units per litre.

  9. Change in Cardiometabolic Biomarkers as measured milligrams per liter

    Time frame: Baseline and 6 months

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

  10. Change in Cardiometabolic Biomarkers Measured in microgram

    Time frame: Baseline and 6 months

    Folate. Measured microgram.

  11. Change in Cardiometabolic Biomarkers Measured picograms per milliliter

    Time frame: Baseline and 6 months

    Vitamin B12. Measured picograms per milliliter.

  12. Change in NIH Toolbox -Oral Reading Recognition Test

    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.

  13. Change in NIH Toolbox Picture Vocabulary Test

    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.

  14. Change in NIH Toolbox- Flanker Inhibitory Control and Attention

    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.

  15. Change in Executive Function measured by Dimensional Change Card Sort Test

    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.

  16. Change in Episodic memory measured by Picture Sequence Memory Test

    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.

  17. Change in NIH Toolbox- Auditory Verbal Learning Test

    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..

  18. Change in Working Memory measured by List Sorting Task

    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.

  19. Change in Processing Speed measured by Patten Comparison Processing Speed Test

    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.

  20. Change in Working Memory measured by Number Span Subset

    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.

  21. Change in Health-related quality of life

    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

  22. Change in Daytime functioning

    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

  23. Changes in Sleep Quality measured by Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance

    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)

  24. Changes in number of minutes as measured by FitBit Sleep Stages

    Time frame: Baseline, 2 months, 6 months

    Sleep quality will be measured by the number of minutes by FitBit Sleep Stages.

  25. Changes in Sleep quality measured by Sleep Score

    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

  26. Change in Cardiometabolic Biomarkers as measured in percentage

    Time frame: Baseline and 6 months

    Hematocrit. Measured as a percentage.

  27. Change in number of calories burned measured by FitBit

    Time frame: Baseline, 2 months, 6 months

    Number of Calories burned

  28. Change in the number of floors climbed measured by Fitbit

    Time frame: Baseline, 2 months

    Number of floors climbed

  29. Change in distance traveled measured in Miles by Fitbit

    Time frame: Baseline, 2 months

    distance traveled measured by mile

  30. Change in number of steps taken measured by Fitbit

    Time frame: Baseline, 2 months

    number of steps taken

  31. Change in Sleep Awakening measured by Fitbit

    Time frame: Baseline, 2 months

    Number of awakenings

Study contacts

Contact information is provided by the study sponsor or research team.

Girardin Jean-Louis, PhD

CONTACT

[email protected]

3052430776

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: PRAISE

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 18, 2023
Registry last updated
May 8, 2025

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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