Nocturnal Hypertension and Nocturia in African American Men

NCT ID: NCT03048734

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-10-31

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.

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.

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group (1): Men with Nocturia ≥2.

No interventions assigned to this group

Group (2): Men with no nocturia (0-1).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• African American Men
• Age 35 to 79 year-old
• Able to give informed consent
• Pass the home sleep study
• Willing to wear the wrist Actigraphy monitor for 9 days continuously.
• Willing to wear ambulatory blood pressure monitoring (ABPM) for 48 hours twice during the 9 days of the study period.

Exclusion Criteria

• Diabetes Mellitus
• Taking Prostate medication
• Symptoms of prostate disease or urinary urgency
• Sleep apnea

1. A neck circumference greater than 17 inches

2. Using Continuous Positive Airway Pressure (CPAP)

3. History of a diagnosis of Sleep Apnea

4. Apnea Hypopnea Index (AHI) > 15 per hour

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Victor, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Other Identifiers

Pro00046856

Identifier Type: -

Identifier Source: org_study_id