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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The primary objective of this study is to determine the longer-term (6 months) effect of CPAP therapy on change in 24-hour mean blood pressure (24hMBP) in OSA subjects with the excessively sleepy symptom subtype.
This is a prospective, non-randomized, observational, two-center study involving newly diagnosed subjects with moderate-severe OSA with the excessively sleepy symptom subtype.
Variables of Interest: Change in 24-hour ambulatory BP, change in sitting BP, change in reaction time by psychomotor vigilance test (PVT)
Participants will complete questionnaires that pertain to demographics, lifestyle factors, and co-morbidities. The blood samples will be used to determine levels of BP medications and serum creatinine. Measurements will be collected at baseline and at 6-month follow-up visits.
Data Analysis Approach: To correct for potential bias in the non-randomized comparison, the investigators will apply a Propensity Score (PS) Design via subclassification. Models to derive the PS values used in this design will include a number of covariates relevant to CPAP adherence, including age, sex, obesity (BMI, neck circumference, waist-to-hip ratio), current smoking, history of hypertension, diabetes mellitus (history, medications), lipid profile, hyperlipidemia (history, medications), family history of premature coronary disease, Charlson comorbidity index, physical activity (IPAQ), diet, OSA severity (AHI, ODI4, T90), sleepiness (Epworth Sleepiness Scale), educational attainment, socioeconomic status (postcode), insomnia symptoms (Insomnia Symptom Questionnaire), anxiety and depression-related symptoms (Patient Health Questionnaire-2), self-efficacy (General self-efficacy scale), and medication adherence (Medication Adherence Report Scale [MARS-5]). Baseline values of outcome measures will also be included in the PS model. After creating the PS design, all analyses are performed accounting for PS subclass as a categorical stratification factor. Evaluations of the CPAP effect on binary outcomes are performed utilizing conditional logistic regression. Similarly, CPAP effects in the context of survival analyses (e.g., Cox Proportional Hazards models) or on continuous outcomes (e.g., linear regression) are assessed by including PS subclass as a categorical covariate in all models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA subjects with the excessively sleepy symptom subtype treated with CPAP | Patients with the excessively sleepy symptom subtype who accept CPAP therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP therapy | Device | CPAP treatment of obstructive sleep apnea with the excessively sleepy symptom subtype |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Mean Blood Pressure | 24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM) | Change from baseline 24-hour Mean Blood Pressure at 6-months after initiation of CPAP therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal Mean BP | Nocturnal Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM) | Change from baseline nocturnal Mean Blood Pressure at 6-months after initiation of CPAP therapy |
| Reciprocal of Reaction Time |
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Inclusion Criteria:
Exclusion Criteria:
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Adults between the ages of 18 to 75 years old with moderate-severe obstructive sleep apnea (OSA) with excessively sleepy symptom subtype. OSA diagnosis will be defined as an apnea/hypopnea index (AHI) >or =5 episodes per hour.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alicia Gonzalez Zacarias, MD | Contact | 6143662361 | alicia.gonzalezzacarias@osumc.edu | |
| Joseph Santiago, RRT | Contact | 6143664756 | joseph.santiago@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ulysses Magalang, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600 | Recruiting | Columbus | Ohio | 43221 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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The blood samples will be used to determine levels of BP medications and serum creatinine
Reciprocal of reaction time obtained by Psychomotor Vigilance Test
| Change from baseline reaction time at 6-months after initiation of CPAP therapy |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |