PM antihypertensive dosing or Chronotherapy for Nocturia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh, Pittsburgh, PA
Nocturia+4 More
PM antihypertensive dosing or Chronotherapy - Other
Eligibility
65+
All Sexes
What conditions do you have?
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Study Summary

In this study the investigators target three common and comorbid illnesses among older adults namely nocturia or waking at night to void, poor sleep and hypertension. The aim of this proposal is to test behavioral sleep intervention to improve sleep and nocturia vs switching the time of antihypertensive administration to improve nighttime and in turn daytime blood pressure control.

Eligible Conditions

  • Nocturia
  • Sleep Disturbance
  • Hypertension

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline and at 6 weeks

Week 6
Mean sleep time systolic blood pressure dip
Nocturia
Pittsburgh Sleep Quality Index (PSQI) score
Sleep efficiency

Trial Safety

Trial Design

3 Treatment Groups

AM antihypertensive dosing arm
1 of 3
BBTI arm
1 of 3
PM antihypertensive dosing or Chronotherapy arm
1 of 3
Active Control
Experimental Treatment

30 Total Participants · 3 Treatment Groups

Primary Treatment: PM antihypertensive dosing or Chronotherapy · No Placebo Group · N/A

BBTI arm
Behavioral
Experimental Group · 1 Intervention: BBTI · Intervention Types: Behavioral
PM antihypertensive dosing or Chronotherapy arm
Other
Experimental Group · 1 Intervention: PM antihypertensive dosing or Chronotherapy · Intervention Types: Other
AM antihypertensive dosing arm
Other
ActiveComparator Group · 1 Intervention: AM antihypertensive dosing · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BBTI
2016
N/A
~100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and at 6 weeks

Trial Background

Prof. Shachi Tyagi, Assistant Professor
Principal Investigator
University of Pittsburgh
Closest Location: University of Pittsburgh · Pittsburgh, PA
Photo of University of Pittsburgh Medical Center   1Photo of University of Pittsburgh Medical Center   2Photo of University of Pittsburgh Medical Center  3
2004First Recorded Clinical Trial
2 TrialsResearching Nocturia
646 CompletedClinical Trials

Eligibility Criteria

Age 65+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of high blood pressure and are taking one or more antihypertensive medications.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.