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Multicomponent Approach for Sleep Disorders, Nocturia, and High Blood Pressure (SHyN Trial)
N/A
Waitlist Available
Led By Shachi Tyagi
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 6 weeks
Awards & highlights
SHyN Trial Summary
This trial will compare two treatments for three common illnesses in older adults: nocturia (waking at night to urinate), poor sleep, and hypertension. One treatment will be a behavioral sleep intervention to improve sleep and nocturia. The other treatment will be switching the time of antihypertensive administration to improve nighttime blood pressure control.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include changes in sleeping patterns or blood pressure levels due to the timing of medication intake or from participating in behavioral therapy.
SHyN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean sleep time systolic blood pressure dip
Secondary outcome measures
Nocturia
Pittsburgh Sleep Quality Index (PSQI) score
Sleep efficiency
SHyN Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: PM antihypertensive dosing or Chronotherapy armExperimental Treatment1 Intervention
participants will be asked to switch their conventional once daily non-diuretic antihypertensive to bedtime
Group II: BBTI armExperimental Treatment1 Intervention
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
Group III: AM antihypertensive dosing armActive Control1 Intervention
participants will be asked to continue taking their antihypertensive medication within an hour of awakening
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BBTI
2016
N/A
~130
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,311 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,005,034 Total Patients Enrolled
Shachi TyagiPrincipal InvestigatorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with or are being treated for obstructive sleep apnea, restless legs syndrome, or parasomnia.You drink more than 14 alcoholic drinks in a week.You have a serious mental health condition that is not being treated.You have a severe, untreated overactive bladder.Your MOCA score is less than 26.You drink more than three caffeinated drinks, which is about 300mg of caffeine, every day.You have more than 30 milliliters of urine left in your bladder after using the bathroom.You have congestive heart failure or high levels of NT-proBNP in your blood.You have a history of high blood pressure and take certain daily medications for it.You have moderate to severe kidney disease.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.You have a history of high blood pressure and are taking certain types of daily medications for it.The study will include older adults who live independently and can move around on their own.The study is for independent men and women over 65 years old who wake up at least twice a night to urinate, have a history of high blood pressure, and are taking specific types of once-daily blood pressure medications.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: AM antihypertensive dosing arm
- Group 2: BBTI arm
- Group 3: PM antihypertensive dosing or Chronotherapy arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research require more participants?
"Affirmative. Per the information on clinicaltrials.gov, this study is currently in search of volunteers to join its ranks; it was initially uploaded on June 1st 2022 and last revised two weeks later. The trial requires 30 participants from one medical centre for completion."
Answered by AI
How many individuals are being taken into consideration for this experiment?
"Affirmative. According to clinicaltrials.gov, this medical experiment is actively searching for enrollees and was posted on June 1st 2022 with the latest update being on June 14th 2022. 30 individuals will be accepted from one site of investigation."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Pennsylvania
What site did they apply to?
University of Pittsburgh
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have all 3 of the issues identified as criteria and I take bp meds 4 times a day and still get bp spikes as high as 150s over 82 at least once week. Morning bp readings range from 137 to 150 when I first wake up.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
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