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

Primary Purpose

Sleep Apnea

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Personalized OSA Treatment
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Apnea

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care Group

Personalized OSA Treatment Group

Arm Description

Participants in this group receive the standard of care treatment for sleep apnea for up to six months.

Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in Molecular Biomarkers
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.
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.
Change in Cardiometabolic Biomarkers 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.
Change in Cardiometabolic Biomarkers as measured in grams per deciliter
Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers measured in mmol/mol
Glucose/HbA1C, Chloride, Potassium, Sodium, Homocysteine. Measured in mmol/mol assessed with blood analyses
Change in Cardiometabolic Biomarkers- platelet count
Platelet Count. Measured per microliter of Blood.
Change in Cardiometabolic Biomarkers as measured per microliter of Blood.
Blood Pressure. Measured per microliter of Blood.
Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.
Thyroid-stimulating hormone. Measured Milli-international units per litre.
Change in Cardiometabolic Biomarkers as measured milligrams per liter
C-reactive protein Highly Sensitive. Measure milligrams per liter.
Change in Cardiometabolic Biomarkers Measured in microgram
Folate. Measured microgram.
Change in Cardiometabolic Biomarkers Measured picograms per milliliter
Vitamin B12. Measured picograms per milliliter.
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.
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.
Change in NIH Toolbox- Flanker Inhibitory Control and Attention
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.
Change in Executive Function measured by Dimensional Change Card Sort Test
Executive function, An assessment of cognitive flexibility and attention. The participant is asked to match a series of picture pairs to a target picture.
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.
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..
Change in Working Memory measured by List Sorting Task
Working memory, An assessment of working memory. The participant is asked to recall and sequence different stimuli that are presented visually and via audio.
Change in Processing Speed measured by Patten Comparison Processing Speed Test
Processing speed, An assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same.
Change in Sustained attention measured by Psychomotor Vigilance Test
Sustained attention, The Psychomotor Vigilance Test (PVT) objectively assesses the mean response time to psychomotor vigilance tests during the Peak Alertness Window.
Change in Neuropsychological Testing (Wechsler Test of Adult Reading
The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability.
Change in Working Memory measured by Number Span Subset
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.
Change in Health-related quality of life
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
Change in Daytime functioning
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
Changes in Sleep Quality measured by Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance
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)
Changes in number of minutes as measured by FitBit Sleep Stages
Sleep quality will be measured by the number of minutes by FitBit Sleep Stages.
Changes in Sleep quality measured by Sleep Score
FitBit Sleep score Min: 1 Max: 100 Excellent: 90-100 Good: 80-89 Fair: 60-79 Poor: Less than 60
Change in Cardiometabolic Biomarkers as measured in percentage
Hematocrit. Measured as a percentage.

Full Information

First Posted
October 12, 2023
Last Updated
October 12, 2023
Sponsor
University of Miami
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT06089161
Brief Title
Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
Acronym
PRAISE
Official Title
Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
Active Comparator
Arm Description
Participants in this group receive the standard of care treatment for sleep apnea for up to six months.
Arm Title
Personalized OSA Treatment Group
Arm Type
Experimental
Arm Description
Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Participants in this group will receive standard of care treatment for sleep apnea.
Intervention Type
Behavioral
Intervention Name(s)
Personalized OSA Treatment
Intervention Description
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 Outcome Measure Information:
Title
Proportion of participants adherence to OSA treatment
Description
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
Up to 6 months
Secondary Outcome Measure Information:
Title
Change in Molecular Biomarkers
Description
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
Title
Change in Vascular Markers
Description
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
Title
Change in Cardiometabolic Biomarkers measured in mg/dl
Description
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
Title
Change in Cardiometabolic Biomarkers as measured in grams per deciliter
Description
Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses.
Time Frame
Baseline and 6 months
Title
Change in Cardiometabolic Biomarkers measured in mmol/mol
Description
Glucose/HbA1C, Chloride, Potassium, Sodium, Homocysteine. Measured in mmol/mol assessed with blood analyses
Time Frame
Baseline and 6 months
Title
Change in Cardiometabolic Biomarkers- platelet count
Description
Platelet Count. Measured per microliter of Blood.
Time Frame
Baseline and 6 months
Title
Change in Cardiometabolic Biomarkers as measured per microliter of Blood.
Description
Blood Pressure. Measured per microliter of Blood.
Time Frame
Baseline and 6 months
Title
Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.
Description
Thyroid-stimulating hormone. Measured Milli-international units per litre.
Time Frame
Baseline and 6 months
Title
Change in Cardiometabolic Biomarkers as measured milligrams per liter
Description
C-reactive protein Highly Sensitive. Measure milligrams per liter.
Time Frame
Baseline and 6 months
Title
Change in Cardiometabolic Biomarkers Measured in microgram
Description
Folate. Measured microgram.
Time Frame
Baseline and 6 months
Title
Change in Cardiometabolic Biomarkers Measured picograms per milliliter
Description
Vitamin B12. Measured picograms per milliliter.
Time Frame
Baseline and 6 months
Title
Change in NIH Toolbox -Oral Reading Recognition Test
Description
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
Title
Change in NIH Toolbox Picture Vocabulary Test
Description
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
Title
Change in NIH Toolbox- Flanker Inhibitory Control and Attention
Description
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
Title
Change in Executive Function measured by Dimensional Change Card Sort Test
Description
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
Title
Change in Episodic memory measured by Picture Sequence Memory Test
Description
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
Title
Change in NIH Toolbox- Auditory Verbal Learning Test
Description
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
Title
Change in Working Memory measured by List Sorting Task
Description
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
Title
Change in Processing Speed measured by Patten Comparison Processing Speed Test
Description
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
Title
Change in Sustained attention measured by Psychomotor Vigilance Test
Description
Sustained attention, The Psychomotor Vigilance Test (PVT) objectively assesses the mean response time to psychomotor vigilance tests during the Peak Alertness Window.
Time Frame
Baseline, 6 months
Title
Change in Neuropsychological Testing (Wechsler Test of Adult Reading
Description
The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability.
Time Frame
Baseline, 6 months
Title
Change in Working Memory measured by Number Span Subset
Description
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, 6 months
Title
Change in Health-related quality of life
Description
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
Title
Change in Daytime functioning
Description
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
Title
Changes in Sleep Quality measured by Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance
Description
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
Title
Changes in number of minutes as measured by FitBit Sleep Stages
Description
Sleep quality will be measured by the number of minutes by FitBit Sleep Stages.
Time Frame
Baseline, 2 months, 6 months
Title
Changes in Sleep quality measured by Sleep Score
Description
FitBit Sleep score Min: 1 Max: 100 Excellent: 90-100 Good: 80-89 Fair: 60-79 Poor: Less than 60
Time Frame
Baseline, 2 months, 6 months
Title
Change in Cardiometabolic Biomarkers as measured in percentage
Description
Hematocrit. Measured as a percentage.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Girardin Jean-Louis, PhD
Phone
3052430776
Email
girardin.jean-louis@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Girardin Jean-Louis, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Girardin Jean-Louis, PhD
Phone
305-243-0776
Email
girardin.jean-louis@miami.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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