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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Wrist-worn vibro-acoustic device, ApolloNeuro, Apollo Neuro, Apollo Wearable for improving sleep duration?

Research on acoustic modulation of sleep suggests that using sound to influence sleep can improve sleep quality. A study on a wearable EEG system showed that delivering sound at specific times during sleep can enhance sleep without disturbing it, indicating potential benefits for similar wearable devices like the Apollo Wearable. ^{1 2 3 4 5}

How does the vibro-acoustic device treatment for sleep duration differ from other treatments?

The vibro-acoustic device is unique because it uses sound and vibration to potentially improve sleep duration, offering a non-invasive and drug-free alternative to traditional sleep aids. Unlike medications or other sleep devices, this treatment focuses on using acoustic signals to influence sleep patterns, which may be more comfortable and accessible for some users. ^{1 6 7 8 9}

Research Team

Paul D Patterson, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Ear-EEG for sleep assessment: a comparison with actigraphy and PSG. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

A wearable EEG system for closed-loop neuromodulation of sleep-related oscillations. [2023]

4. United States 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. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Case comparison of sleep features from ear-EEG and scalp-EEG. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Long-term ear-EEG monitoring of sleep - A case study during shift work. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Sleep-quality assessment from full night audio recordings of sleep apnea patients. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Pattern recognition of sleep in rodents using piezoelectric signals generated by gross body movements. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a sleep switch device. [2019]