NCT05419830: SHyN

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

Completed NA Results posted Last updated 17 December 2024

What this trial tests

NA trial testing BBTI in Nocturia in 30 participants. Completed in 30 January 2024.

Timeline

1 June 2022

Primary endpoint
30 November 2023

30 January 2024

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	30
Start date	1 June 2022
Primary completion	30 November 2023
Estimated completion	30 January 2024
Sites	1 location across United States

Drugs / interventions tested

• BBTI
• PM antihypertensive dosing or Chronotherapy
• AM antihypertensive dosing

Conditions studied

• Nocturia — all drugs for Nocturia →
• Hypertension — all drugs for Hypertension →
• Sleep Disturbance — all drugs for Sleep Disturbance →

Sponsor

University of Pittsburgh

Who can join

65 and older, any sex, with Nocturia or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention Primary · Baseline and at 6 weeks

The mean sleep time systolic blood pressure dip will be quantified by calculating the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value for each participant across the 48-hour recording period comparing baseline and post-intervention

Group	Value	95% CI
AM Antihypertensive Dosing Arm	-0.4	± 7.9
BBTI Arm	7.3	± 13.5
PM Antihypertensive Dosing or Chronotherapy Arm	3.9	± 10.0

Change in Nocturia Frequency Pre- vs Post-intervention Secondary · Baseline and at 6 weeks

change in nocturia frequency pre- vs post-intervention as determined by 3-day bladder diary completed at both time points

Group	Value	95% CI
AM Antihypertensive Dosing Arm	-0.3	± 1.0
BBTI Arm	-0.6	± 0.7
PM Antihypertensive Dosing or Chronotherapy Arm	-0.3	± 0.8

Change in Nocturnal Polyuira Index (NPi) Pre vs Post-intervention Secondary · Baseline and at 6 weeks

NPi is calculated using nighttime and daytime urine volumes as reported in 3-day bladder diary as follows: NPi=(nocturnal urine volume/24-hour volume)\*100

Group	Value	95% CI
AM Antihypertensive Dosing Arm	0.5	± 7.4
BBTI Arm	-6.0	± 9.7
PM Antihypertensive Dosing or Chronotherapy Arm	-0.9	± 7.6

Change in Global Pittsburgh Sleep Quality Index (PSQI) Score Pre- vs Post-intervention Secondary · Baseline and at 6 weeks

PSQI is a self-rated questionnaire for evaluating subjective sleep quality. PSQI global scores range from 0-21, with higher scores indicating worse sleep quality and negative change indicates sleep improvement.

Group	Value	95% CI
AM Antihypertensive Dosing Arm	0.5	± 2.9
BBTI Arm	-1.4	± 2.2
PM Antihypertensive Dosing or Chronotherapy Arm	-1.2	± 3.7

Change in Sleep Efficiency Pre- vs Post-intervention Secondary · Baseline and at 6 weeks

Sleep efficiency will be calculated as (total sleep time/time in bed)\*100 with time in bed and total sleep times obtained from Zmachine worn by participants pre- and post-intervention

Group	Value	95% CI
AM Antihypertensive Dosing Arm	-7	± 15.3
BBTI Arm	12	± 7.8
PM Antihypertensive Dosing or Chronotherapy Arm	-3	± 11.8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.