Wrist device to improve sleep and performance for night shift workers
Effect of Vibro-acoustic Stimulation on Night Shift Worker Sleep, Alertness, and Recovery (The Sleep Vibe Study)
This study is testing a wrist device to see if it can help night shift workers sleep better and perform their jobs more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06665672 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of a wrist-worn vibro-acoustic device, the ApolloNeuro, on sleep duration and psychomotor performance among night shift workers. The study will utilize a laboratory-based, randomized crossover design with 24 participants, assessing the device's impact on sleep quality, heart rate variability, and subjective sleep ratings during and after simulated night shifts. The findings will inform future larger-scale studies based on the proof of concept established in this trial.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18 and older who are public safety or healthcare shift workers.
Not a fit: Patients with medical conditions affecting blood pressure or cardiovascular health may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly enhance sleep quality and performance for individuals working night shifts.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in improving sleep and performance among shift workers.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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 this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Paul D Patterson, PhD — University of Pittsburgh
- Study coordinator: Paul D Patterson, PhD
- Email: pdp3@pitt.edu
- Phone: 412-647-3078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.