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

Effect of Vibro-acoustic Stimulation on Night Shift Worker Sleep, Alertness, and Recovery (The Sleep Vibe Study)

NCT06665672•Daniel Patterson, PhD, NRP

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. are 18 years of age or older;
•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 / nicotine products during the protocol and data collection;
•4. can abstain from alcohol and moderate to high intensity exercise during the protocol and data collection;
•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 application of non-invasive devices on the wrist, upper arm, or chest for purposes of data collection with non-invasive devices;
•7. feel that they can avoid working and complete the study protocol without interruption.
•8. a public safety or healthcare shift worker based on standard licensing / certification requirements in the state of Pennsylvania.

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 the study protocol that involves abstaining from alcohol, tobacco products (nicotine), and moderate to intense exercise during the study protocol and data collection periods;
•4. have a physical condition that may limit use of non-invasive devices applied to the wrist, upper arm, or chest for data collection purposes.
•5. being pregnant.
•6. "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.
+5 more criteria

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

November 26, 2024

Primary Completion Date

January 31, 2026

Completion Date

March 31, 2026

Last Updated

October 3, 2025

Enrollment

ESTIMATED participants

Conditions

Sleep DurationPsychomotor Performance

Interventions

Wrist worn vibro-acoustic device

DEVICE

Contacts

Paul D Patterson, PhD

CONTACT

412-647-3078 pdp3@pitt.edu

Hypknowledge Nationwide Sleep Extension

NCT07345767

Short Sleep Duration

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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