Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT03048734
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nocturnal Hypertension and Nocturia in African American Men
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
A Pilot Study : Nocturnal Hypertension and Nocturia in African American Men
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the results show that uncontrolled systolic hypertension is independent determinantal of nocturia in African American men.
We now went to pursue this correlation by designing a new NIH grant Proposal to determine whether replacing short acting with long acting drugs and dosing them at bed time rather than in the morning will:
A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to nocturia in some patients.
We now went to pursue this correlation by designing a new NIH grant Proposal to determine whether replacing short acting with long acting drugs and dosing them at bed time rather than in the morning will:
A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to nocturia in some patients.
Detailed Description:
AIMS AND SIGNIFICANCE OF PILOT DATA
Determine:
1. The feasibility of Southern California registry as an effective measure to recruit African American men to participate in a new research program.
2. If men will comply with the study procedures including Actigraphy and ambulatory blood pressure monitors.
3. The within subject coefficient of variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure monitoring, vertical activity at night by Actigraphy monitors.
4. Whether the ambulatory Blood pressure itself affects the sleep pattern on Actigraphy.
5. Nocturnal systolic blood pressure and nocturnal vertical activity are higher in men with self-reported nocturia ≥2 at night than in men with no reported nocturia.
Purpose:
Obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.
Determine:
1. The feasibility of Southern California registry as an effective measure to recruit African American men to participate in a new research program.
2. If men will comply with the study procedures including Actigraphy and ambulatory blood pressure monitors.
3. The within subject coefficient of variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure monitoring, vertical activity at night by Actigraphy monitors.
4. Whether the ambulatory Blood pressure itself affects the sleep pattern on Actigraphy.
5. Nocturnal systolic blood pressure and nocturnal vertical activity are higher in men with self-reported nocturia ≥2 at night than in men with no reported nocturia.
Purpose:
Obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: