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

Sleep Apnea Clinical Trial

— PRAISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089161
• Other study ID #: 20220509
• Secondary ID: 5R01AG075007-02
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Girardin Jean-Louis, PhD
• Phone: 3052430776
• Email: girardin.jean-louis[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Standard of Care
Participants in this group will receive standard of care treatment for sleep apnea.

Behavioral:
• Personalized OSA Treatment
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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 6 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 6 months
Secondary	Change in Cardiometabolic Biomarkers as measured in grams per deciliter	Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses.	Baseline and 6 months
Secondary	Change in Cardiometabolic Biomarkers measured in mmol/mol	Glucose/HbA1C, Chloride, Potassium, Sodium, Homocysteine. Measured in mmol/mol assessed with blood analyses	Baseline and 6 months
Secondary	Change in Cardiometabolic Biomarkers- platelet count	Platelet Count. Measured per microliter of Blood.	Baseline and 6 months
Secondary	Change in Cardiometabolic Biomarkers as measured per microliter of Blood.	Blood Pressure. Measured per microliter of Blood.	Baseline and 6 months
Secondary	Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.	Thyroid-stimulating hormone. Measured Milli-international units per litre.	Baseline and 6 months
Secondary	Change in Cardiometabolic Biomarkers as measured milligrams per liter	C-reactive protein Highly Sensitive. Measure milligrams per liter.	Baseline and 6 months
Secondary	Change in Cardiometabolic Biomarkers Measured in microgram	Folate. Measured microgram.	Baseline and 6 months
Secondary	Change in Cardiometabolic Biomarkers Measured picograms per milliliter	Vitamin B12. Measured picograms per milliliter.	Baseline and 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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..	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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	Baseline, 2 months, 6 months
Secondary	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	Baseline, 2 months, 6 months
Secondary	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)	Baseline, 2 months, 6 months
Secondary	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.	Baseline, 2 months, 6 months
Secondary	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	Baseline, 2 months, 6 months
Secondary	Change in Cardiometabolic Biomarkers as measured in percentage	Hematocrit. Measured as a percentage.	Baseline and 6 months