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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 below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cognitive or neurological disorders like dementia, Parkinson's, or Multiple Sclerosis.

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I am currently taking medication to help me sleep or stay awake.

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I have high blood pressure despite taking more than 4 medications.

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I am experiencing significant depression.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Awards & 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

0 / 6Eligibility criteria met