Clinical trial NCT06665672: Effect of a Wrist-worn Device That Produces a Small Vibration on Sleep and Performance That Can Occur During and After Night Shift Work
Official title: Effect of Vibro-acoustic Stimulation on Night Shift Worker Sleep, Alertness, and Recovery (The Sleep Vibe Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Duration
Psychomotor Performance
Keywords: Night shifts
Sleep duration
Nap
Shift work
Performance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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 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).

Primary outcomes:
measure: Mean sleep duration
timeFrame: 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:
measure: Mean number of lapses in psychomotor performance at 10 minutes after participants wake from sleep period
timeFrame: 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..
measure: Proportion with a dip in systolic blood pressure during 30-min nap opportunity that is greater than or equal to 10%
timeFrame: During the 30-min nap opportunity that occurs during the simulated 24-hour night shift
measure: Proportion with a dip in systolic blood pressure during the 5-hour recovery sleep period
timeFrame: During the 5-hour recovery sleep period that occurs after the 24-hour simulated night shift
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Paul D Patterson, PhD
role: PRINCIPAL_INVESTIGATOR
References: