Acute Sleep Loss and Arterial Stiffness

June 1, 2024 updated by: Daniel Patterson, PhD, NRP, University of Pittsburgh
The overarching goal of this study is to mimic a night shift work like schedule and characterize circadian variation in Pulse Wave Velocity (PWV), a measure of arterial stiffness, and determine the impact of acute loss of sleep like that experienced by shift workers on PWV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Night shift work is associated with increased risk of cardiovascular disease (CVD). Pulse wave velocity (PWV) is a commonly used non-invasive measure of arterial stiffness and is strongly associated with CVD. Previous research links sleep loss, like that experienced by shift workers, to elevated levels or abnormal levels of PWV. In addition, there is some research that shows circadian variation in PWV, which has implications for future studies and when PWV should be assessed. The overarching goal of this study is to characterize circadian variation in PWV and determine the impact of acute loss of sleep on PWV during a schedule like that experienced by night shift workers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Daniel Patterson
  • Phone Number: 412-647-3078
  • Email: pdp3@pitt.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

An individual may be eligible to participate if they meet the following criteria:

  1. are between the ages of 20 and 29 years;
  2. have not been diagnosed or told by a healthcare clinician that they have a medical condition that may impact their blood pressure or cardiovascular health/system;
  3. can abstain from smoking tobacco or chewing tobacco products;
  4. can abstain from caffeine and exercise for 4 days in a row;
  5. are not prescribed medications or take over the counter medications that may impact blood pressure or heart rate (a team physician will review any reported medications identified during screening);
  6. do not have a physical condition that may interfere with using the upper arm, upper thigh, or access to the neck area for purposes of performing non-invasive measures linked to this protocol; and
  7. feel that they can avoid working and complete the 4 day protocol without interruption.

Exclusion Criteria:

An individual will be excluded if they report:

  1. a medical condition or diagnosis that may impact their blood pressure or heart rate;
  2. taking any standing medications or prescriptions, other than over the counter medications or contraceptives, that may impact their blood pressure or heart rate;
  3. are unable to adhere to a strict 4 day protocol that involves abstaining from caffeine, alcohol, tobacco products (nicotine), and exercise;
  4. have a physical condition that may limit use of the upper arm or upper thigh or area around the neck, which is necessary for performing multiple non-invasive measures associated with this protocol.
  5. being pregnant.

Because participants may awaken during the in-lab sleep opportunity when staff use the Sphygmocor device, it is important that staff and the study team know if the participant has ever experienced the following:

A] Sleep Paralysis; B] Night Terrors; C] Have Obstructive Sleep Apnea which requires the use of a CPAP Device; D] Become angry towards others when abruptly woken up; E] Become physical towards others when abruptly woken up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sleep Loss
Participants will undergo a night shift work like schedule and be monitored with non-invasive devices while at-home (at set intervals) and during an in-lab phase (hourly) during a 97 continuous-hour protocol. During the in-lab phase, which is approximately 48 continuous hours, participants will undergo a 24-hour period of sleep loss, followed by a brief opportunity for an in-lab sleep opportunity of 5 hours, followed by another period of 19 hours of sleep loss before returning home for at-home monitoring. Measures of interest include arterial stiffness as measured by pulse wave velocity (PWV) and changes in subjective ratings (e.g., fatigue and sleepiness). Other measures include cognitive performance, total sleep during the protocol, and sleep depth during an in-lab sleep opportunity.
Other: Sleep Loss
Participants will undergo periods of sleep loss in a laboratory setting and be monitored hourly for changes in indicators of arterial stiffness (i.e., pulse wave velocity).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Circadian changes in pulse wave velocity (PWV)
Time Frame: Over 48 hours during in-lab phase.
Circadian (day/night) variation in arterial stiffness as measured by pulse wave velocity (PWV) during the in-lab phase of the protocol during periods of sleep loss. Average PWV (in meters per second m/s) measures calculated over daylight hours compared to the average PWV measures calculated over nighttime hours.
Over 48 hours during in-lab phase.
Changes in pulse wave velocity (PWV) in response to 24 hours of acute sleep loss
Time Frame: First 24 hours of the in-lab phase of the study protocol.
Arterial stiffness as measured by pulse wave velocity (PWV) in meters per second during the in-lab phase of the study protocol. The in-lab measurement compared to the 24th hour measurement.
First 24 hours of the in-lab phase of the study protocol.
Changes in pulse wave velocity (PWV) in response to 48 hours of acute sleep loss
Time Frame: 48 hours of the in-lab phase of the study protocol.
Arterial stiffness as measured by pulse wave velocity (PWV) in meters per second during the in-lab phase of the study protocol. The first in-lab measurement compared to the 48th hour measurement.
48 hours of the in-lab phase of the study protocol.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleepiness first 24 hours of acute sleep loss
Time Frame: First 24 hours of the in-lab phase of the study protocol.
Changes in subjectively rated sleepiness in response to sleep loss using a single-item question with response options ranging from 0= Not At All to 5= Very Much. The first in-lab measurement compared to the 24th hour measurement.
First 24 hours of the in-lab phase of the study protocol.
Sleepiness at 48 hours of acute sleep loss
Time Frame: 48 hours of the in-lab phase of the study protocol.
Changes in subjectively rated sleepiness in response to sleep loss using a single-item question with response options ranging from 0= Not At All to 5= Very Much. The first in-lab measurement compared to the 48th hour measurement.
48 hours of the in-lab phase of the study protocol.
Fatigue first 24 hours of acute sleep loss
Time Frame: First 24 hours of the in-lab phase of the study protocol.
Changes in subjectively rated fatigue in response to sleep loss using a single-item question with response options ranging from 0= Not At All to 5= Very Much. The first in-lab measurement compared to the 24th hour measurement.
First 24 hours of the in-lab phase of the study protocol.
Fatigue at 48 hours of acute sleep loss
Time Frame: 48 hours of the in-lab phase of the study protocol.
Changes in subjectively rated fatigue in response to sleep loss using a single-item question with response options ranging from 0= Not At All to 5= Very Much. The first in-lab measurement compared to the 48th hour measurement.
48 hours of the in-lab phase of the study protocol.
Pulse wave analysis first 24 hours of acute sleep loss
Time Frame: First 24 hours of the in-lab phase of the study protocol.
Non-invasive measure of central augmentation index (as a percentage) will be assessed at set intervals during the protocol. The first in-lab measurement compared to the 24th hour measurement.
First 24 hours of the in-lab phase of the study protocol.
Pulse wave analysis at 48 hours of acute sleep loss
Time Frame: 48 hours of the in-lab phase of the study protocol.
Non-invasive measure of central augmentation index (as a percentage) will be assessed at set intervals during the protocol. The first in-lab measurement compared to the 48th hour measurement.
48 hours of the in-lab phase of the study protocol.
Cognitive performance first 24 hours of acute sleep loss
Time Frame: First 24 hours of the in-lab phase of the study protocol.
Cognitive performance as measured by the Psychomotor Vigilance Test Brief (PVT-B) as measured by lapses (reaction time >355ms). The first in-lab measurement compared to the 24th hour measurement.
First 24 hours of the in-lab phase of the study protocol.
Cognitive performance at 48 hours of acute sleep loss
Time Frame: 48 hours of the in-lab phase of the study protocol.
Cognitive performance as measured by the Psychomotor Vigilance Test Brief (PVT-B) as measured by lapses (reaction time >355ms). The first in-lab measurement compared to the 48th hour measurement.
48 hours of the in-lab phase of the study protocol.
Sleep depth
Time Frame: As measured during the in-lab 5-hour sleep opportunity.
Sleep depth as measured by portable electroencephalogram (EEG) and reported as total minutes of deep sleep during the in-lab sleep opportunity.
As measured during the in-lab 5-hour sleep opportunity.
Total sleep duration
Time Frame: Total sleep duration (in minutes) during the entire protocol (over 97 hours).
Total sleep duration (in minutes) as measured by wrist-worn actigraphy over the entire 97 hour study protocol.
Total sleep duration (in minutes) during the entire protocol (over 97 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Patterson, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY23030068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigators do not have a defined plan to share data with outside investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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