The Influence of Sleep on Cardiovascular Outcomes

NCT06535178 | Recruiting

• 1 other identifier: STUDY00026854
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to identify the effects of sleep regularity on cardiovascular regulatory mechanisms. The investigators are hoping to discover if improving the regularity of sleep timing will improve metabolic and vascular health markers. The protocol is a 12-week prospective cohort study that includes both field and in-laboratory data collection in ostensibly healthy male and female adults, aged 18-40years. We will also have a sub-group of individuals with chronic pain to examine the effects of sleep regularity on pain outcomes.

Conditions

Circadian Rhythm; Cardiometabolic Health; Vascular Health; Pain

Keywords

Circadian Rhythm; Cardiometabolic Health; Vascular Health; Pain

Outcome Measures

Primary Outcomes (10)

• Changes in dim-light melatonin onset

  Saliva samples will be collected pre- and post-12-week intervention and will be assayed for melatonin using standardized assays. Dim-light melatonin onset will be calculated using the linear interpolated point in time in which each participant's melatonin crosses and remains elevated above a 4pg/mL threshold. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in SRI

  SRI will be calculated from 2-weeks actigraphy data prior to the first in-laboratory visit. Changes in SRI will be measured for 2-weeks during Weeks 1-2, Weeks 6-7, and Weeks 11-12 for the intervention group and during Weeks 11-12 for the control group. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in vascular endothelial function

  Vascular endothelial function will be assessed via flow mediated dilation pre- and post-12-week intervention. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in heart rate

  Heart rate will be measured every \~30 minutes via a blood pressure cuff. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in blood pressure

  Changes in resting blood pressure will be measured every \~30 minutes via ambulatory blood pressure machines for up to 48-hours during Weeks 1-2, Weeks 6-7, and Weeks 11-12 for the intervention group and Weeks 11-12 for the control group. Blood pressure patterns during the day and night will be assessed, as well as a contrast of day and nighttime blood pressure levels. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in resting cardiac vagal tone

  High frequency power of the heart rate variability power spectrum will be used to estimate cardiac parasympathetic activity (vagal tone). These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in heart rate response to exercise

  Beat by beat heart rate will be recorded during a Monark bicycle ergometer exercise test where workload will be increased every 3-min until \~75% age predicted heart rate max is achieved. Heart rate will be averaged at rest, during each 3-min stage, and each minute during a 2-minute recovery. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in blood pressure response to exercise

  Beat by beat blood pressure will be recorded during a Monark bicycle ergometer exercise test. Blood pressure will be averaged at rest, during each 3-min stage, and each minute during a 2-minute recovery. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in energy metabolism

  Resting energy expenditure and macronutrient oxidation will be measured via indirect calorimetry. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

• Changes in glucose

  Changes in glucose will be measures during Weeks 1-2, Weeks 6-7, and Weeks 11-12 for the intervention group and Weeks 11-12 for the control group. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.

  Week 0 and Week 12

Secondary Outcomes (9)

• Changes in MDA

  Week 0 and Week 12

• Changes in TAC

  Week 0 and Week 12

• Changes in CRP

  Week 0 and Week 12

• Changes in triglycerides

  Week 0 and Week 12

• Changes in percent body fat

  Week 0 and Week 12

Study Arms (2)

Sleep Regularity Group

EXPERIMENTAL

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).

Behavioral: Sleep Regularity Group

Control Group

NO INTERVENTION

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

Interventions

Sleep Regularity Group BEHAVIORAL

Maintained consistent sleep onset time (±30 min self-selected sleep time) for 12-weeks.

Sleep Regularity Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ostensibly healthy men and women Subgroup study (chronic pain)
• Satisfies diagnostic criteria for fibromyalgia according to the Widespread Pain Index - Symptom Severity (WPI-SS) scale with the following three conditions being met:
• Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3-6 and SS scale score ≥9.
• Symptoms have been present at a similar level for at least 3 months.
• The patient does not have a disorder that would otherwise explain the pain.

You may not qualify if:

• No history of drug or alcohol dependency.
• Must be current non-smokers, and are required to have a history of less than 5 pack years of smoking.
• No history of working irregular day and night hours, regular night work, or rotating shift work for the 1 year prior to the study. In addition to this, individuals must not have traveled across more than 1 time zone during the 3 months prior to the study.
• Chronobiologic and sleep disorders.
• Diseases of the cardiovascular system.
• Hypertension. Individuals will be allowed to be normotensive (resting systolic blood pressure of \<140/90 mmHg, measured on more than one occasion) or uncomplicated stage 1 hypertension (systolic BP between 140 and 159 mmHg or a diastolic BP between 90 and 99 mmHg).
• Disorders of the respiratory system.
• Pre-diabetes/Diabetes. For participants who have self-reported pre-diabetes/diabetes.
• Disorders of the kidney and urinary tract.
• Infectious diseases.
• Disorders of the gastrointestinal system.
• Disorders of the immune system.
• Disorders of the hematopoietic system.
• Neoplastic diseases.
• Endocrine and metabolic diseases.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Medical Research Foundation, Oregon: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew W McHill, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew W McHill, PhD

CONTACT

(503) 494 - 2594; mchill@ohsu.edu

Brooke M Shafer

CONTACT

(503) 494 - 0670; shaferb@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 2, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)