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Behavioral Intervention

Sleep Regularity for Cardiovascular Health (DISCO Trial)

N/A

Recruiting

Led By Andrew W McHill, PhD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Must be current non-smokers with a history of less than 5 pack years of smoking

Pre-diabetes/Diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 and week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate how having a consistent sleep schedule affects the body's cardiovascular functions. The researchers want to see if improving the regularity of sleep timing can lead to better metabolic and vascular health.

Who is the study for?

This trial is for healthy men and women aged 18-40 who are interested in how sleep patterns affect heart health. Participants should have a regular daily routine but may have varying sleep schedules. The study excludes those with known cardiovascular or metabolic disorders, shift workers, pregnant individuals, and anyone on medication affecting sleep or circadian rhythms.

What is being tested?

The study is examining the impact of consistent sleep times on heart and blood vessel health over a 12-week period. It involves tracking participants' normal life routines as well as specific assessments conducted in a lab setting to measure changes in their cardiometabolic health.

What are the potential side effects?

Since this trial focuses on non-invasive monitoring of sleep patterns rather than testing drugs or medical procedures, there are minimal expected side effects. However, some inconvenience due to schedule adjustments or discomfort from wearing monitoring devices during the study might occur.

Eligibility Criteria

Exclusion Criteria

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

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I currently do not smoke and have smoked less than 5 pack years.

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I have pre-diabetes or diabetes.

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My blood pressure is normal or I have mild hypertension.

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I have a blood disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in SRI

Changes in blood pressure

Changes in blood pressure response to exercise

+7 more

Secondary study objectives

Changes in BMI

Changes in CRP

Changes in MDA

+5 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

Active Control

Group I: Sleep Regularity GroupExperimental Treatment1 Intervention

Individuals in the lowest SRI tertile will begin the 12-week intervention to improve sleep regularity. Participants will be instructed to maintain a consistent sleep onset time (±30 min self-selected sleep time).

Group II: Control GroupActive Control1 Intervention

All other participants will be instructed to maintain their habitual sleep patterns.

0 / 4Eligibility criteria met