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

NCT05419830 | Completed Results

• 2 other identifiers: STUDY210501321R33AG057806
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturia; Hypertension; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention

  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

  Baseline and at 6 weeks

Secondary Outcomes (4)

• Change in Nocturia Frequency Pre- vs Post-intervention

  Baseline and at 6 weeks

• Change in Nocturnal Polyuira Index (NPi) Pre vs Post-intervention

  Baseline and at 6 weeks

• Change in Global Pittsburgh Sleep Quality Index (PSQI) Score Pre- vs Post-intervention

  Baseline and at 6 weeks

• Change in Sleep Efficiency Pre- vs Post-intervention

  Baseline and at 6 weeks

Study Arms (3)

AM (morning) antihypertensive dosing arm or Control arm

ACTIVE COMPARATOR

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

Other: AM antihypertensive dosing

BBTI arm

EXPERIMENTAL

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

Behavioral: BBTI

PM (evening) antihypertensive dosing or Chronotherapy arm

EXPERIMENTAL

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

Other: PM antihypertensive dosing or Chronotherapy

Interventions

BBTI 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.

BBTI arm

PM antihypertensive dosing or Chronotherapy OTHER

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

PM (evening) antihypertensive dosing or Chronotherapy arm

AM antihypertensive dosing OTHER

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

AM (morning) antihypertensive dosing arm or Control arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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) \<26
• Currently diagnosed and/or treated Obstructive Sleep Apnea, Restless Legs Syndrome, parasomnia
• Congestive heart failure, by exam
• Chronic kidney disease, stage III-V (eGFR\<60)
• \>14 alcohol drinks per week
• \>3 caffeinated drinks (\~300mg) per day

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Nocturia; Hypertension; Parasomnias

Interventions

Chronotherapy

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Shachi Tyagi, MD, MS
• Organization: University of Pittsburgh

sht55@pitt.edu

4126471274

Study Officials

• Shachi Tyagi

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: June 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: January 30, 2024
• Last Updated: December 17, 2024
• Results First Posted: December 17, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)