MedDataX Logo

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

NCT ID: NCT05419830

Last Updated: 2024-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators posit that a vicious cycle operates between nocturia, poor sleep, and nighttime hypertension (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 systolic blood pressure (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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nocturia Hypertension Sleep Disturbance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The randomization envelopes will be prepared by the study statistician. Randomization and the intervention BBTI will be completed by research nurse and PI and the outcome assessor will be blinded to randomization.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AM (morning) antihypertensive dosing arm or Control arm

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

Group Type ACTIVE_COMPARATOR

AM antihypertensive dosing

Intervention Type OTHER

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

BBTI arm

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

Group Type EXPERIMENTAL

BBTI

Intervention Type BEHAVIORAL

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.

PM (evening) antihypertensive dosing or Chronotherapy arm

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

Group Type EXPERIMENTAL

PM antihypertensive dosing or Chronotherapy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BBTI

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 BEHAVIORAL

PM antihypertensive dosing or Chronotherapy

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

Intervention Type OTHER

AM antihypertensive dosing

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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. Montreal cognitive assessment (MOCA) \<26
6. Currently diagnosed and/or treated Obstructive Sleep Apnea, Restless Legs Syndrome, parasomnia
7. Congestive heart failure, by exam
8. Chronic kidney disease, stage III-V (eGFR\<60)
9. \>14 alcohol drinks per week
10. \>3 caffeinated drinks (\~300mg) per day
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shachi Tyagi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shachi Tyagi

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R33AG057806

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21050132

Identifier Type: -

Identifier Source: org_study_id