Circadian Rhythms and Cardiovascular Risk

NCT ID: NCT02202811

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2020-03-09

Brief Summary

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The purpose of this study is to understand how behaviors and the effects of the body's internal clock (called the circadian pacemaker) affect the control of the heart and blood pressure.

People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian phase in some of the same key indices of CV risk. The investigators hypothesize that such changes, taken together, may explain the different timing of heart attack and sudden cardiac death in OSA.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Obstructive Sleep Apnea

Forced Desynchrony, OSA

Group Type EXPERIMENTAL

Forced Desynchrony

Intervention Type BEHAVIORAL

all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.

Control

Forced Desynchrony, Control

Group Type PLACEBO_COMPARATOR

Forced Desynchrony

Intervention Type BEHAVIORAL

all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.

Interventions

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Forced Desynchrony

all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI less than 40
* Moderate to severe OSA (AHI)\>15
* No current or previous pharmacological treatment for hypertension
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Saurabh Thosar

Saurabh S. Thosar, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven A Shea, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Thosar SS, Berman AM, Herzig MX, McHill AW, Bowles NP, Swanson CM, Clemons NA, Butler MP, Clemons AA, Emens JS, Shea SA. Circadian Rhythm of Vascular Function in Midlife Adults. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1203-1211. doi: 10.1161/ATVBAHA.119.312682.

Reference Type DERIVED
PMID: 31070470 (View on PubMed)

Other Identifiers

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OSA 00010101

Identifier Type: -

Identifier Source: org_study_id

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