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Lack of funding.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Loss | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Loss | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
An individual may be eligible to participate if they meet the following criteria:
Exclusion Criteria:
An individual will be excluded if they report:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Patterson | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
Investigators do not have a defined plan to share data with outside investigators.
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This is a prospective study whereby participants undergo periods of sleep loss
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| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |