RECRUITING

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

Conditions

Sleep Duration Psychomotor Performance Night shifts Nap Shift work Performance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-26

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06665672

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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)?

Inclusion Criteria

Exclusion 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.

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)?

Contacts and Locations

Study Contact

Paul D Patterson, PhD

CONTACT

412-647-3078

pdp3@pitt.edu

Principal Investigator

Paul D Patterson, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261

United States

Collaborators and Investigators

Sponsor: Daniel Patterson, PhD, NRP

Paul D Patterson, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2024-11-26

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

Night shifts
Sleep duration
Nap
Shift work
Performance

Additional Relevant MeSH Terms

Sleep Duration
Psychomotor Performance