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Completed

NCT Number: NCT03048734

Nocturnal Hypertension and Nocturia in African American Men

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.

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Key information

Age range

35 year–79 year

Sex eligibility

Male

Study type

Observational

About this study

AIMS AND SIGNIFICANCE OF PILOT DATA

Determine:

  • The feasibility of Southern California registry as an effective measure to recruit African American men to participate in a new research program.
  • If men will comply with the study procedures including Actigraphy and ambulatory blood pressure monitors.
  • 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.
  • Whether the ambulatory Blood pressure itself affects the sleep pattern on Actigraphy.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • A neck circumference greater than 17 inches
  • Using Continuous Positive Airway Pressure (CPAP)
  • History of a diagnosis of Sleep Apnea
  • Apnea Hypopnea Index (AHI) > 15 per hour

Treatment and study plan

Primary outcomes

  1. Number of events of Nocturia in relation to blood pressure.

    Time frame: 9 days

    will evaluate the patients with how many times they go to the bathroom and assess the relation with their nocturnal blood pressure.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

A Pilot Study : Nocturnal Hypertension and Nocturia in African American Men

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2017
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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