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Sleep Extension for High Blood Pressure (STITCH Trial)
N/A
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65
Be older than 18 years old
Must not have
History of cognitive or neurological disorders (e.g. dementia, Parkinson's, Multiple Sclerosis)
Use of hypnotic or stimulant medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if extending sleep can help reduce risk factors for cardiovascular disease and improve health behaviors in adults with hypertension and short sleep duration.
Who is the study for?
Adults aged 18-65 with high blood pressure or hypertension, sleeping less than 7 hours a night, and using a smartphone can join. They must be stable on blood pressure meds if taking any, not have severe depression or serious illnesses like cancer, avoid heavy alcohol use, and not work overnight shifts more than once a month.
What is being tested?
The trial is testing whether teaching people to sleep longer can improve their heart health and reduce risks for diseases related to high blood pressure. Participants will either receive sleep extension coaching or general health education.
What are the potential side effects?
Since the interventions involve behavioral changes rather than medications, side effects are minimal but may include potential stress from lifestyle adjustments or increased time commitment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of cognitive or neurological disorders like dementia, Parkinson's, or Multiple Sclerosis.
Select...
I am currently taking medication to help me sleep or stay awake.
Select...
I have high blood pressure despite taking more than 4 medications.
Select...
I am experiencing significant depression.
Select...
I do not have any serious illnesses that would prevent me from participating.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
24 hour ambulatory blood pressure
Sleep duration
Other study objectives
C-reactive protein (CRP)
Diet
HbA1c
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Health educationExperimental Treatment1 Intervention
Participants in the health education group will receive 8 weekly health education emails and telephone calls to confirm their receipt and clarify any concepts from the materials. In months 3-6, they will receive monthly health education materials.
Group II: Behavioral sleep extension groupExperimental Treatment1 Intervention
Participants in the sleep extension group will receive a fitbit, weekly coaching calls and educational materials for 8 weeks. In months 3-6, they will receive educational materials and an email from the coach each month.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health education
2018
Completed Phase 3
~9500
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
602 Previous Clinical Trials
10,377,749 Total Patients Enrolled
University of Illinois at ChicagoOTHER
639 Previous Clinical Trials
1,568,666 Total Patients Enrolled
University of UtahLead Sponsor
1,145 Previous Clinical Trials
1,698,717 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious sleep disorder, such as obstructive sleep apnea, restless legs syndrome, or severe insomnia.My average blood pressure is between 115-145/75-90 mmHg, and I've been on a stable dose of blood pressure medication for over 8 weeks.I have a history of cognitive or neurological disorders like dementia, Parkinson's, or Multiple Sclerosis.I am between 18 and 65 years old.You drink too much alcohol, as determined by a questionnaire.You typically sleep less than 7 hours and spend less than 8 hours in bed, as measured by a special device.I am currently taking medication to help me sleep or stay awake.You have a history of drug use that is considered risky according to a specific screening test.I have high blood pressure despite taking more than 4 medications.You have severe mental illnesses like schizophrenia or bipolar disorder.You have a very high body mass index (BMI) or large arm circumference.You use a smartphone.I am experiencing significant depression.You have regular caregiving responsibilities for young children, elderly, or disabled adults that may affect your ability to get enough sleep.I do not have any serious illnesses that would prevent me from participating.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral sleep extension group
- Group 2: Health education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.