Effect of a Wrist-worn Device That Produces a Small Vibration on Sleep and Performance That Can Occur During and After Night Shift Work

Completed · Not applicable

Conditions studied: Sleep Duration, Psychomotor Performance

In brief

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.

Key facts

Study ID

NCT06665672

Run by

Daniel Patterson, PhD, NRP

People needed

21

Starts

2024-11-26

Expected to finish

2025-12-12

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• are 18 years of age or older;
• 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;
• can abstain from smoking tobacco or chewing tobacco / nicotine products during the protocol and data collection;
• can abstain from alcohol and moderate to high intensity exercise during the protocol and data collection;
• 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);
• do not have a physical condition that may interfere with application of non-invasive devices on the wrist, upper arm, or chest for purposes of data collection with non-invasive devices;
• feel that they can avoid working and complete the study protocol without interruption.
• a public safety or healthcare shift worker based on standard licensing / certification requirements in the state of Pennsylvania.

You may not qualify if…

• An individual will be excluded if they report:
• a medical condition or diagnosis that may impact their blood pressure or heart rate;
• taking any standing medications or prescriptions, other than over the counter medications or contraceptives, that may impact their blood pressure or heart rate;
• are unable to adhere to the study protocol that involves abstaining from alcohol, tobacco products (nicotine), and moderate to intense exercise during the study protocol and data collection periods;
• have a physical condition that may limit use of non-invasive devices applied to the wrist, upper arm, or chest for data collection purposes.
• being pregnant.
• "heavy" alcohol use as defined by the CDC (8 or more drinks per week in women or 15 or more drinks per week in men)?
• Because participants will have their sleep interrupted during the in-lab sleep opportunity, 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.
• Mild annoyance and feelings of fatigue or sleepiness with being woken by staff is expected and not a reason for exclusion in this research study.
• Answering YES to any of the above (A-E) will result in a discussion with the study team physician to discuss with the individual and make a determination if the individual can or should participate in this research study.
• All who voluntarily participate should be without significant health issues and without health concerns that may affect their blood pressure.
• All who voluntarily participate should not be on medications that fall within the following categories:
• A] Antihypertensives; B] Analgesics; C] Beta blockers; D] Diuretics; E] Stimulants; F] Sedatives; G] Steroids.
• Participants must not take any medications with sedative effects or effects on sleep during the study protocol and data collection periods (such as NyQuil).

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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