Acute Sleep Loss and Arterial Stiffness

Arterial Stiffness Clinical Trial

Official title:

Acute Sleep Loss and Arterial Stiffness

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05940467
• Other study ID #: STUDY23030068
• Status: Terminated
• Phase: N/A
• Start date: July 11, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Stiffness

Intervention

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).

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleepiness first 24 hours of acute sleep loss	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.
Other	Sleepiness at 48 hours of acute sleep loss	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.
Other	Fatigue first 24 hours of acute sleep loss	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.
Other	Fatigue at 48 hours of acute sleep loss	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.
Other	Pulse wave analysis first 24 hours of acute sleep loss	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.
Other	Pulse wave analysis at 48 hours of acute sleep loss	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.
Other	Cognitive performance first 24 hours of acute sleep loss	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.
Other	Cognitive performance at 48 hours of acute sleep loss	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.
Other	Sleep depth	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.
Other	Total sleep duration	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).
Primary	Circadian changes in pulse wave velocity (PWV)	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.
Primary	Changes in pulse wave velocity (PWV) in response to 24 hours of acute sleep loss	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.
Primary	Changes in pulse wave velocity (PWV) in response to 48 hours of acute sleep loss	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.