N/A N=30 Randomized Double-blind Other

Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses

Nocturia · Hypertension · Sleep Disturbance

Bottom Line

View on ClinicalTrials.gov: NCT05419830 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention — -0.4; 7.3; 3.9 percentage of daytime mean SBP — p=0.65

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BBTI (Behavioral); PM antihypertensive dosing or Chronotherapy (Other); AM antihypertensive dosing (Other)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention	-0.4; 7.3; 3.9	0.65
SECONDARY Change in Nocturia Frequency Pre- vs Post-intervention	-0.3; -0.6; -0.3	0.66
SECONDARY Change in Nocturnal Polyuira Index (NPi) Pre vs Post-intervention	0.5; -6.0; -0.9	0.14
SECONDARY Change in Global Pittsburgh Sleep Quality Index (PSQI) Score Pre- vs Post-intervention	0.5; -1.4; -1.2	0.2
SECONDARY Change in Sleep Efficiency Pre- vs Post-intervention	-7; 12; -3	0.02 sig

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.

Eligibility Criteria

Inclusion Criteria

The study shall include: ambulatory and functionally-independent community-dwelling men and women aged 65+ years, with

nocturia ≥2/night, and
history of high blood pressure and receives one or more non-diuretic, once daily antihypertensive- angiotensin converting enzyme inhibitor (ACE-I), angiotensin receptor blocker (ARB), calcium channel blocker (CCB), beta blocker

Exclusion Criteria

Unstable or acute medical or central nervous system conditions
Untreated, current, severe psychiatric condition
Untreated, current, severe overactive bladder syndrome
Post void residual > 30ml
Montreal cognitive assessment (MOCA) 14 alcohol drinks per week
>3 caffeinated drinks (~300mg) per day

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Data sourced from ClinicalTrials.gov (NCT05419830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.