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 |
|