Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of lapses in psychomotor performance at 10 minutes after participants wake from sleep period | The 3-minute Psychomotor Vigilance Test Brief (PVT-B) is a reliable and valid measure of psychomotor performance. Investigators will assess the number of PVT-B Lapses for each participant measured at 10 minutes after waking from the 30-minute simulated shift nap opportunity. Number of Lapses is measured as a count and ranges from 0 to 50 or more during a single test. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
An individual will be excluded if they report:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul D Patterson, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
De-identified study data may be provided to researchers at the University of Pittsburgh, other institutions and/or federal repositories for the purposes of collaboration on the proposed research. Sharing will be completed under an approved sharing agreement.
December 2026
Reviewed on a case by case basis
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be blinded to the condition (arm) when the ApolloNeuro device is to be applied.
|
| 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% | The proportion of participants with a dip in systolic blood pressure (SBP) during the 30-min nap opportunity. SBP dipping - defined as - as ((mean wake hours SBP - mean sleep SBP divided by mean wake hours SBP) X 100). The percentage can range from 0 to 100. | 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 | The proportion of participants with a dip in systolic blood pressure (SBP) during the 5-hour recovery sleep period. SBP dipping - defined as - ((mean wake hours SBP - mean sleep SBP divided by mean wake hours SBP) x 100). The percentage can range from 0 to 100. | During the 5-hour recovery sleep period that occurs after the 24-hour simulated night shift |