The overarching goal of this research study is to determine "proof of concept" of effect of a non-invasive sleep aid device on sleep and performance during sleep opportunities (naps) that occur during and after simulated night shift work. Aim 1: To determine the effect of the ApolloNeuro device on sleep duration, sleep architecture, blood pressure, heart rate variability, and subjective ratings of sleep quality during and after simulated night shift work. Aim 2: To determine the effect of the ApolloNeuro device on post-sleep psychomotor performance.
Night shift workers suffer from poor sleep quality, high levels of fatigue, and irregular sleep patterns. The overarching goal of this research study is to determine "proof of concept" of effect of a non-invasive sleep aid device on sleep and performance during sleep opportunities (naps) that occur during and after simulated night shift work. The device is commercially available and worn on the wrist (the ApolloNeuro). We will use a laboratory-based, randomized crossover trial with two conditions tested. With 24 total subjects enrolled and 20 total completing the study as designed, we have 80% power to detect a moderate to large effect size difference between the two conditions tested. Study findings will guide a "go-no-go" decision for future, large-sample studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
21
The Apollo device is a wrist worn device that is similar to a typical wristwatch. It emits a vibration pattern based on settings selected on a designated mobile app.
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Mean sleep duration
Sleep duration is measured in minutes
Time frame: Two time points examined. First, from the start of the simulated night shift 30-minute nap opportunity to the end at 30 minutes. Second, from the start of the recovery sleep period starting at 9am and ending at 2pm.
Mean number of lapses in psychomotor performance at 10 minutes after participants wake from sleep period
The 3-minute Psychomotor Vigilance Test Brief (PVT-B) is a reliable and valid measure of psychomotor performance. Investigators will assess the number of PVT-B Lapses for each participant measured at 10 minutes after waking from the 30-minute simulated shift nap opportunity. Number of Lapses is measured as a count and ranges from 0 to 50 or more during a single test.
Time frame: Measured at two time points. First, measured at 10 minutes after waking from the 30-minute nap opportunity during the simulated night shift. Second, measured at 10 minutes after participants wake from the 5-hour recovery sleep period..
Proportion with a dip in systolic blood pressure during 30-min nap opportunity that is greater than or equal to 10%
The proportion of participants with a dip in systolic blood pressure (SBP) during the 30-min nap opportunity. SBP dipping - defined as - as ((mean wake hours SBP - mean sleep SBP divided by mean wake hours SBP) X 100). The percentage can range from 0 to 100.
Time frame: During the 30-min nap opportunity that occurs during the simulated 24-hour night shift
Proportion with a dip in systolic blood pressure during the 5-hour recovery sleep period
The proportion of participants with a dip in systolic blood pressure (SBP) during the 5-hour recovery sleep period. SBP dipping - defined as - ((mean wake hours SBP - mean sleep SBP divided by mean wake hours SBP) x 100). The percentage can range from 0 to 100.
Time frame: During the 5-hour recovery sleep period that occurs after the 24-hour simulated night shift
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