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

NCT06665672 | Recruiting FDA Device

• 1 other identifier: STUDY24060106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Duration; Psychomotor Performance

Keywords

Night shifts; Sleep duration; Nap; Shift work; Performance

Outcome Measures

Primary Outcomes (1)

• Mean sleep duration

  Sleep duration is measured in minutes

  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.

Secondary Outcomes (3)

• Mean number of lapses in psychomotor performance at 10 minutes after participants wake from sleep period

  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%

  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

  During the 5-hour recovery sleep period that occurs after the 24-hour simulated night shift

Study Arms (2)

Apollo device applied followed by no device applied

EXPERIMENTAL

Participants will be randomized to first wear the Apollo Neuro device immediately before, during, and immediately after sleep opportunities during the study protocol. Next, the participant will complete the protocol without the device.

Device: Wrist worn vibro-acoustic device

No device applied followed by the Apollo device applied

EXPERIMENTAL

Participants will be randomized to first complete the protocol without the Apollo Neuro device applied then complete a condition with the Apollo Neuro device applied immediately before, during, and immediately after sleep opportunities during the study protocol.

Device: Wrist worn vibro-acoustic device

Interventions

Wrist worn vibro-acoustic device DEVICE

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.

Also known as: Apollo

Apollo device applied followed by no device applied; No device applied followed by the Apollo device applied

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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).

Sponsors & Collaborators

• Daniel Patterson, PhD, NRP: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

Study Officials

• Paul D Patterson, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul D Patterson, PhD

CONTACT

412-647-3078; pdp3@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the condition (arm) when the ApolloNeuro device is to be applied.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: November 26, 2024
• Primary Completion: January 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: December 2026
• Access Criteria: Reviewed on a case by case basis

Locations

US (1)