Multicomponent Approach for Sleep Disorders, Nocturia, and High Blood Pressure

(SHyN Trial)

Overseen by Shachi Tyagi

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pittsburgh

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Shachi Tyagi

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for men and women aged 65 or older who are able to move around on their own, have high blood pressure treated with certain non-diuretic medications, and wake up at least twice a night to urinate. It's not for those with sleep apnea, severe psychiatric conditions, heavy alcohol use, certain heart or kidney diseases.

Inclusion Criteria

You have a history of high blood pressure and take certain daily medications for it.

You are a man or woman aged 65 or older who lives independently and experiences waking up to urinate at least twice during the night.

You wake up to pee at least 2 times during the night.

Exclusion Criteria

You have been diagnosed with or are being treated for obstructive sleep apnea, restless legs syndrome, or parasomnia.

Unstable or acute medical or central nervous system conditions

You drink more than 14 alcoholic drinks in a week.

Treatment Details

Interventions

• AM antihypertensive dosing (Other)
• BBTI (Behavioural Intervention)
• PM antihypertensive dosing or Chronotherapy (Other)

Trial Overview The study tests if changing the timing of blood pressure medication (PM vs AM dosing) or using behavioral therapy for better sleep can improve nighttime bathroom visits and control daytime blood pressure in older adults.

Participant Groups

Group I: PM (evening) antihypertensive dosing or Chronotherapy arm Experimental Treatment 1 Intervention

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

Group II: BBTI arm Experimental Treatment 1 Intervention

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 III: AM (morning) antihypertensive dosing arm or Control arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School