Vibro-acoustic Device for Sleep Duration

(Sleep-Vibe Trial)

Overseen By Paul D Patterson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Daniel Patterson, PhD, NRP

Must not be taking: Antihypertensives, Analgesics, Beta blockers, others

Disqualifiers: Pregnancy, Obstructive sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a wrist-worn device, the ApolloNeuro, can improve sleep and performance during and after simulated night shift work. Researchers seek to understand if the device can enhance sleep quality, heart health, and post-nap alertness. Participants will sleep both with and without the device to compare results. This trial may suit public safety or healthcare workers in Pennsylvania who have no heart or blood pressure issues and can abstain from alcohol and tobacco during the study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance sleep and performance for shift workers.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that affect blood pressure or heart rate, as well as any sedatives or medications that impact sleep during the study.

What prior data suggests that this device is safe for improving sleep?

Research has shown that the Apollo Neuro device, a wristband that gently vibrates to aid stress and sleep, is generally safe for use. Over a dozen studies have tested it, finding that most people experience no major side effects.

The device is non-invasive, meaning it does not enter the body, which reduces the risk of harm. Some users might feel mild discomfort from the vibrations, but serious issues are rare. Additionally, the Apollo Neuro device is available for sale as a tool to help people relax and sleep better, indicating its safety for general use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the vibro-acoustic device for sleep duration because it offers a non-invasive way to potentially improve sleep quality. Unlike traditional sleep aids like medications, which can have side effects or lead to dependency, this device uses gentle vibrations and sound waves to promote relaxation and better sleep. This innovative approach could provide a safer, drug-free alternative that works by naturally enhancing the body's ability to rest. By wearing the device on the wrist before, during, and after sleep, users might experience improved sleep duration without the typical drawbacks of current treatments.

What evidence suggests that this vibro-acoustic device is effective for improving sleep?

Research suggests that the ApolloNeuro device, a wristband using gentle vibrations, may improve sleep and relaxation. In this trial, participants will experience both conditions—using the ApolloNeuro device and not using it—to assess its impact on sleep duration. Studies have shown that using the device for more than three hours a day, five days a week, can lead to better sleep over three months. Users have reported falling asleep faster, sleeping longer, and feeling more relaxed. The device calms the nervous system with its gentle vibrations. While these results are promising, more research is needed to confirm these effects, especially for people who work night shifts. ^{2 4 6 7 8}

Who Is on the Research Team?

Paul D Patterson, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals who work night shifts and are interested in testing a wrist-worn device designed to improve sleep and performance. Participants should be willing to have their sleep, heart rate variability, blood pressure, and motor skills monitored.

Inclusion Criteria

Participants must abstain from alcohol and moderate to high-intensity exercise during the protocol and data collection

Participants must be public safety or healthcare shift workers based on standard licensing/certification requirements in the state of Pennsylvania

I am not taking any medication that affects my blood pressure or heart rate.

Exclusion Criteria

I have a condition that affects my blood pressure or heart rate.

Pregnant individuals

Individuals with 'heavy' alcohol use as defined by the CDC

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulated Night Shift

Participants undergo simulated night shift work with and without the ApolloNeuro device to assess its effect on sleep and performance.

1 week

Multiple sessions in a controlled laboratory setting

Recovery Sleep Period

Participants engage in a 5-hour recovery sleep period to measure the effects of the ApolloNeuro device on sleep and physiological parameters.

5 hours

In-lab monitoring

Follow-up

Participants are monitored for safety and effectiveness after the trial phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wrist-worn vibro-acoustic device

Trial Overview The study tests the ApolloNeuro device's ability to enhance sleep duration and quality during/after night shifts. It also examines its impact on psychomotor performance post-sleep by monitoring vital signs and subjective sleep assessments.

How Is the Trial Designed?

Group I: No device applied followed by the Apollo device applied Experimental Treatment 1 Intervention

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.

Group II: Apollo device applied followed by no device applied Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Daniel Patterson, PhD, NRP

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

A novel non-contact method for analyzing sleep quality was developed, utilizing acoustic signal processing to detect sleep-related disorders in 145 patients with obstructive sleep apnea, based on over 1000 hours of recorded audio signals.

The system demonstrated an accuracy of 82.1% in detecting sleep/wake states, with relatively low errors in measuring sleep latency (3.9%) and total sleep time (11.4%), indicating its potential effectiveness for diagnosing sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep-quality assessment from full night audio recordings of sleep apnea patients. Dafna, E., Tarasiuk, A., Zigel, Y.[2020]

The sleep switch device demonstrated a very high correlation (0.98) with polysomnography (PSG) in measuring sleep latency, making it a reliable tool for assessing how quickly individuals fall asleep.

While the sleep switch was slightly less accurate than wrist actigraphy in measuring total sleep time, it remains an effective and cost-efficient option for evaluating sleep patterns in both insomniacs and normal sleepers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a sleep switch device. Hauri, PJ.[2019]

This paper provides a comprehensive overview of how acoustic stimuli can be used to enhance sleep, discussing various methods, their advantages and disadvantages, and the differences in outcomes measured, such as subjective versus objective effects.

It highlights the importance of considering individual differences and environmental factors when studying the effects of acoustic input on sleep, suggesting that both therapeutic and adverse acoustic influences can significantly impact sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated Review of the Acoustic Modulation of Sleep: Current Perspectives and Emerging Concepts. Cordi, MJ.[2021]

A novel in-the-ear electroencephalography (EEG) device can effectively record brain activity related to sleep, showing clear patterns like alpha activity and sleep spindles, similar to traditional scalp EEG.

The hypnograms derived from ear EEG were found to be 90.9% similar to those from standard scalp EEG, suggesting that this new method is a reliable alternative for sleep staging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case comparison of sleep features from ear-EEG and scalp-EEG. Zibrandtsen, I., Kidmose, P., Otto, M., et al.[2022]

A new noninvasive method using piezoelectric films can accurately monitor sleep and wake states in rodents by detecting respiratory movements, achieving about 95% accuracy in classification.

This innovative approach is cost-effective and could facilitate large-scale studies on sleep, including genetic research and testing the effects of sleep-related drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pattern recognition of sleep in rodents using piezoelectric signals generated by gross body movements. Flores, AE., Flores, JE., Deshpande, H., et al.[2022]

The study evaluated three ear-EEG setups for automatic sleep staging using data from 80 full-night recordings of 20 healthy subjects, finding that the cross-ear configuration achieved the highest accuracy with a kappa value of 0.72, indicating good agreement with the gold standard polysomnography.

Both the single-ear with ipsilateral mastoid and cross-ear setups outperformed wrist-worn actigraphy in sleep metrics, suggesting that ear-EEG configurations could provide a more reliable alternative for sleep monitoring compared to traditional actigraphy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ear-EEG for sleep assessment: a comparison with actigraphy and PSG. Tabar, YR., Mikkelsen, KB., Rank, ML., et al.[2021]

The Jawbone UP3 fitness tracker significantly overestimated total sleep time by about 39.6 minutes compared to polysomnography (PSG), indicating it may not provide accurate sleep duration measurements for patients with hypersomnolence.

While the JB3 showed high sensitivity in detecting sleep (97%), it struggled to classify different sleep stages and failed to identify any sleep onset rapid eye movement periods (SOREMPs), making it unsuitable as a replacement for PSG or Multiple Sleep Latency Tests in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ability of the Multisensory Jawbone UP3 to Quantify and Classify Sleep in Patients With Suspected Central Disorders of Hypersomnolence: A Comparison Against Polysomnography and Actigraphy. Cook, JD., Prairie, ML., Plante, DT.[2019]

The ear-electroencephalography device demonstrated substantial agreement with traditional polysomnography, achieving a Cohen's kappa of 0.72, indicating it can reliably assess sleep stages over long-term use.

This wearable technology is unobtrusive and effective for monitoring sleep in real-world conditions, making it a promising tool for both clinical and research applications in sleep analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term ear-EEG monitoring of sleep - A case study during shift work. Jørgensen, SD., Kidmose, P., Mikkelsen, K., et al.[2023]

The study successfully developed a wearable device that uses an advanced algorithm to track brain wave phases in real-time, allowing for precise delivery of auditory stimulation to enhance sleep quality.

Preliminary results indicate that this closed-loop system can safely administer stimulation during the transition from wakefulness to sleep without negatively affecting sleep onset, suggesting its potential for improving overall sleep health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable EEG system for closed-loop neuromodulation of sleep-related oscillations. Bressler, S., Neely, R., Yost, RM., et al.[2023]

Citations

1. apolloneuro.com apolloneuro.com/?srsltid=AfmBOop0jYACdAVDSorPVSAB0yatZfRLkl8nmh5ywOEpcB_IY3w6EWWr

Apollo Neuro: Touch Therapy Tech for Stress, Sleep ... The Apollo stress relief touch therapy wearable helps you relax, sleep better, and feel better. Uncover your best self today.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06665672

Study Details | NCT06665672 | Effect of a Wrist-worn ... 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 ...

3. apolloneuro.com apolloneuro.com/pages/apollo-neuro-research?srsltid=AfmBOooIH-1HXnM5JdgeboLMAbsHH6mW-cWSF326uQzPmLDx7xUf5aDK

Apollo Neuro Research Those who use the Apollo wearable consistently (3+ hours a day, 5+ days a week, during the day and night) over 3 months see the biggest improvements in sleep ...

4. amazon.com amazon.com/Apollo-Neuro-Wearable-Relaxation-Recovery/dp/B0BWYX2GB5

Apollo Neuro Wearable – Award-Winning Sleep & Stress ... Amazon.com: Apollo Neuro Wearable – Award-Winning Sleep & Stress Relief Device – Fall Asleep Faster, Sleep Longer – Calm Stress, Boost Focus & Relaxation ...

5. trial.medpath.com trial.medpath.com/clinical-trial/37feabccdd1563b5/nct05685121-wearable-wrist-nerve-stimulator-autonomic-dysfunction

A Wrist-Worn Nerve Stimulator for Remediating Persistent Post ... The primary aim of this study is to evaluate the effectiveness of the Apollo Neuro Device on remediating clinical symptoms, cognitive deficits and physical ...

6. apolloneuro.com apolloneuro.com/?srsltid=AfmBOopZ1dYf9SmshrnbiZ5OzZrvYbbo_Hret6lBoBjMESQnwr_jqoOb

Apollo Neuro: Touch Therapy Tech for Stress, Sleep ... The Apollo stress relief touch therapy wearable helps you relax, sleep better, and feel better. Uncover your best self today.

7. apolloneuro.com apolloneuro.com/pages/apollo-neuro-research?srsltid=AfmBOoqlhu7HGWprGpvSwdfeT6SwphhYcgVPR5zoYZtpMQrZypvz5zIM

Apollo Neuro Research The Apollo technology's efficacy and safety have been validated in over a dozen independent and university-led trials, and there are more studies in ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395625005552

The effect of the Apollo Neuro device on anxiety among ... The Apollo Neuro, a wearable vibration device that acts non-invasively to reduce anxiety levels, was tested as an add-on to ketamine therapy. •. The Apollo ...