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

Primary Purpose

Nocturia, Hypertension, Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BBTI
PM antihypertensive dosing or Chronotherapy
AM antihypertensive dosing
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nocturia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

  1. nocturia ≥2/night, and
  2. 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:

  1. Unstable or acute medical or central nervous system conditions
  2. Untreated, current, severe psychiatric condition
  3. Untreated, current, severe overactive bladder syndrome
  4. Post void residual > 30ml
  5. MOCA <26
  6. Currently diagnosed and/or treated Obstructive Sleep Apnea, Restless Legs Syndrome, parasomnia
  7. CHF, by exam or NT-proB natriuretic peptide (NT-proBNP)> 30 pmol/L56
  8. Chronic kidney disease, stage III-V (eGFR<60)
  9. >14 alcohol drinks per week
  10. >3 caffeinated drinks (~300mg) per day

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

AM antihypertensive dosing arm

BBTI arm

PM antihypertensive dosing or Chronotherapy arm

Arm Description

participants will be asked to continue taking their antihypertensive medication within an hour of awakening

participants will receive the behavioral treatment for insomnia BBTI by the study RN. Participants will also be asked to take their antihypertensive medication within an hour of awakening

participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime

Outcomes

Primary Outcome Measures

Mean sleep time systolic blood pressure dip
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

Secondary Outcome Measures

Nocturia
nocturia frequency per 3-day bladder diary completed by participants comparing baseline and post-intervention
Pittsburgh Sleep Quality Index (PSQI) score
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.
Sleep efficiency
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

Full Information

First Posted
June 10, 2022
Last Updated
August 3, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05419830
Brief Title
Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses
Acronym
SHyN
Official Title
Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The investigators posit that a vicious cycle operates between nocturia, poor sleep, and nighttime HTN. HTN act through the pressure-natriuresis mechanism that links sodium (Na) and BP homeostasis: periodic increases in BP drive compensatory renal excretion of Na (natriuresis) and water (diuresis) to reduce blood volume and BP. Normally, BP and natriuresis declines during sleep, decreasing nighttime urine volume (NUV). Elevated nighttime BP increases nocturnal natriuresis causing an increase in nighttime urine volume and hence, NP: the major etiologic factor for nocturia in the elderly. In a recently completed study (AG050892, PI:Tyagi), it was found that poor sleep blunts the normal nighttime rise in antidiuretic hormone-a potent Na conserving hormone, which leads to nocturnal natriuresis and, as a result, NP. Hence, our model incorporates the effects of poor sleep and nighttime HTN on natriuresis, NP, and nocturia. The investigators postulate that treatments targeted towards these etiologies will help break this vicious cycle. Traditionally, antihypertensive medications are dosed in the morning targeting daytime BP. However, some research suggests that nighttime BP best predicts risk for major cardiovascular events. Several clinical trials of bedtime dosing of BP medication-chronotherapy- show better nighttime BP control. However, no clinical studies have considered or tested chronotherapy as a treatment for nocturia. With respect to poor sleep, the investigators have shown that brief behavioral treatment of insomnia (BBTI) significantly improves not only sleep but also self-reported nocturia among the elderly. Therefore, the investigators envision a multicomponent approach with chronotherapy (bedtime dosing of certain antihypertensives) and behavioral sleep intervention (BBTI) to concurrently address the prevalent and chronic, mutually exacerbating conditions: nocturia, poor sleep, and HTN. The current proposal aims to collect pilot data for a definitive randomized clinical trial. In the proposed pilot study 30 community-dwelling older adults (aged >65) who take at ≥1 daily non-diuretic antihypertensive medication, have a mean SBP >135 mm Hg, and awaken ≥2 times nightly to void will be randomly assigned to one of the 3 groups of 10 participants each to 1) morning (am) HTN medication dosing, 2) BBTI with am HTN medication dosing, 3) nighttime non-diuretic HTN medication dosing (chronotherapy) for 6 weeks. At baseline and 6 weeks, participants will undergo 48-hour ambulatory BP monitoring, in-home sleep study, complete a 3-day bladder diary. This protocol will allow the investigators to accomplish following Aims: Aim1: To assess the feasibility and effect of chronotherapy and BBTI in older adults with multiple comorbidities: HTN and nocturia Hypothesis 1: Chronotherapy and BBTI will be (a) feasible treatment options among comorbid older adults, and (b) nocturia and nighttime urine volume, and (c) nighttime SBP will have a greater decrease in BBTI and chronotherapy groups than usual care. Aim 2: Assess safety and treatment compliance with chronotherapy. Hypothesis 2: The investigators will assess treatment compliance and also collect data on nocturnal lightheadedness and falls to begin to address the safety of HTN chronotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia, Hypertension, Sleep Disturbance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In the proposed pilot study 30 community-dwelling older adults (aged >65) who take at ≥1 daily non-diuretic antihypertensive medication, have a mean SBP >135 mm Hg, and awaken ≥2 times nightly to void will be randomly assigned to one of the 3 groups of 10 participants each to 1) morning (am) HTN medication dosing, 2) BBTI with am HTN medication dosing, 3) nighttime non-diuretic HTN medication dosing (chronotherapy) for 6 weeks.
Masking
InvestigatorOutcomes Assessor
Masking Description
The randomization envelopes will be prepared by the study statistician. Randomization and the intervention BBTI will be completed by research RN and PI and the outcome assessor will be blinded to randomization.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AM antihypertensive dosing arm
Arm Type
Active Comparator
Arm Description
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
Arm Title
BBTI arm
Arm Type
Experimental
Arm Description
participants will receive the behavioral treatment for insomnia BBTI by the study RN. Participants will also be asked to take their antihypertensive medication within an hour of awakening
Arm Title
PM antihypertensive dosing or Chronotherapy arm
Arm Type
Experimental
Arm Description
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
Intervention Type
Behavioral
Intervention Name(s)
BBTI
Intervention Description
Participants randomized to BBTI will receive 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later, and 20-minute telephone calls after 1 and 3 weeks. BBTI will focus on four behaviors that promote sleep and discussion of homeostatic and circadian mechanisms of human sleep regulation. These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
Intervention Type
Other
Intervention Name(s)
PM antihypertensive dosing or Chronotherapy
Intervention Description
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
Intervention Type
Other
Intervention Name(s)
AM antihypertensive dosing
Intervention Description
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
Primary Outcome Measure Information:
Title
Mean sleep time systolic blood pressure dip
Description
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
Time Frame
Baseline and at 6 weeks
Secondary Outcome Measure Information:
Title
Nocturia
Description
nocturia frequency per 3-day bladder diary completed by participants comparing baseline and post-intervention
Time Frame
Baseline and at 6 weeks
Title
Pittsburgh Sleep Quality Index (PSQI) score
Description
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.
Time Frame
Baseline and at 6 weeks
Title
Sleep efficiency
Description
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
Time Frame
Baseline and at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 MOCA <26 Currently diagnosed and/or treated Obstructive Sleep Apnea, Restless Legs Syndrome, parasomnia CHF, by exam or NT-proB natriuretic peptide (NT-proBNP)> 30 pmol/L56 Chronic kidney disease, stage III-V (eGFR<60) >14 alcohol drinks per week >3 caffeinated drinks (~300mg) per day
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shachi Tyagi, MD
Phone
4126471274
Email
sht55@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kandy Newell, RN
Phone
4126471270
Email
kln40@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shachi Tyagi
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shachi Tyagi, MD, MS
Phone
412-647-1274
Email
sht55@pitt.edu
First Name & Middle Initial & Last Name & Degree
Kandy L Newell, RN
Phone
412.647.1271
Email
kln40@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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