Sleep DurationSleep-VibeNCT06665672
Effect of a Wrist-worn Device That Produces a Small Vibration on Sleep and Performance That Can Occur During and After Night Shift Work
A study testing Wrist worn vibro-acoustic device in people with Sleep Duration and Psychomotor Performance, run by Daniel Patterson, PhD, NRP at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Duration, Psychomotor Performance
- What is being tested?
- Wrist worn vibro-acoustic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- "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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Effect of Vibro-acoustic Stimulation on Night Shift Worker Sleep, Alertness, and Recovery (The Sleep Vibe Study)
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.
Read the 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.
- Conditions
- Sleep Duration, Psychomotor Performance
- Being tested
- Wrist worn vibro-acoustic device
- Keywords
- Night shifts, Sleep duration, Nap, Shift work, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist worn vibro-acoustic deviceDevice
Also called Apollo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Wrist worn vibro-acoustic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sleep duration
Sleep duration is measured in minutes
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: During the 5-hour recovery sleep period that occurs after the 24-hour simulated night shift
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start26 Nov 2024
- Primary completion11 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DurationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Patterson, PhD, NRP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Patterson, PhD, NRP, University of Pittsburgh
- Investigators
- Paul D Patterson, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665672
- Sponsor's protocol ID
- STUDY24060106
- Acronym
- Sleep-Vibe
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibro-acoustic Stimulation on Night Shift Worker Sleep, Alertness, and Recovery (The Sleep Vibe Study)
- ClinicalTrials.gov ID
- NCT06665672
- Acronym / sponsor ID
- Sleep-Vibe / STUDY24060106
- Conditions
- Sleep Duration, Psychomotor Performance
- Keywords
- Night shifts, Sleep duration, Nap, Shift work, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Daniel Patterson, PhD, NRPUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apollo device applied followed by no device applied | Experimental | Device: Wrist worn vibro-acoustic deviceParticipants 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 | Device: Wrist worn vibro-acoustic deviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist worn vibro-acoustic deviceAlso: ApolloThe 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. | Device | Apollo device applied followed by no device applied, No device applied followed by the Apollo device applied |
Primary outcome
Mean sleep duration
Time frame: 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.
Sleep duration is measured in minutes
3 secondary outcomes
Mean number of lapses in psychomotor performance at 10 minutes after participants wake from sleep period
Time frame: 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%
Time frame: 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
Time frame: During the 5-hour recovery sleep period that occurs after the 24-hour simulated night shift
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul D Patterson, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist worn vibro-acoustic device in people with Sleep Duration and Psychomotor Performance, run by Daniel Patterson, PhD, NRP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sleep duration (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.