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Sleep Extension for High Blood Pressure (STITCH Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
STITCH Trial 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.Check my eligibility
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.See study design
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.
STITCH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
STITCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
24 hour ambulatory blood pressure
Sleep duration
Other outcome measures
C-reactive protein (CRP)
Diet
HbA1c
+2 moreSTITCH 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
580 Previous Clinical Trials
10,376,444 Total Patients Enrolled
University of Illinois at ChicagoOTHER
608 Previous Clinical Trials
1,559,397 Total Patients Enrolled
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,602 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research endeavor still open?
"The clinicaltrials.gov webpage confirms that this experiment is still actively recruiting participants, with the initial post date of March 30th 2021 and most recent update on July 20th 2022."
Answered by AI
Who meets the criteria to be part of this clinical trial?
"The current clinical trial is accepting 120 adult patients who have been diagnosed with hypertension and can meet the following criteria: 18-65 years of age, 8 hours or less in bed per night, no more than 7 hours asleep based on actigraphy data and must own a smartphone."
Answered by AI
Is there an age restriction for participation in this clinical study?
"This medical trial is open to subjects aged between 18 and 65."
Answered by AI
How many people are taking part in this clinical experiment?
"That is correct. Clinicaltrials.gov confirms that this investigation, which was first posted on March 30th 2021, continues to be actively recruiting participants. The research team needs 120 people from a single medical centre for the trial to proceed."
Answered by AI
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