Acoustic Stimulation for Sleep Deprivation

Overseen By John D Hughes, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Walter Reed Army Institute of Research (WRAIR)

Disqualifiers: Cardiovascular, Neurologic, Pulmonary, Kidney, 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

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine if brief sounds or tones presented within a restricted period of recovery sleep after a period of sleep deprivation will enhance restorative properties and improve performance during a subsequent period of wakefulness.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that certain medications may not be allowed on a case-by-case basis. It's best to discuss your specific medications with the trial coordinators.

Is acoustic stimulation for sleep generally safe for humans?

Research on acoustic stimulation for sleep, including devices like Philips SmartSleep, suggests it is generally safe for humans. Studies have focused on enhancing sleep quality and slow-wave activity without reporting significant safety concerns. ^{1 2 3 4 5}

How does the Philips SmartSleep Acoustic Stimulation Device treatment differ from other treatments for sleep deprivation?

The Philips SmartSleep Acoustic Stimulation Device is unique because it uses sound to enhance slow-wave sleep, which is important for memory and brain health, unlike other treatments that may not focus on this specific sleep phase. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Philips SmartSleep Acoustic Stimulation Device for sleep deprivation?

Research shows that audio stimulation, when synchronized with brain activity, can help people fall asleep faster and improve sleep quality. Additionally, auditory stimulation has been found to increase REM sleep, which is important for recovery and overall sleep health. ^{1 4 7 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-39 who understand the study well (score at least 80% on a quiz), speak English as their first language, have a BMI below 30, sleep normally without disorders or irregularities, and don't use certain substances or medications. Pregnant women and regular smokers are excluded.

Inclusion Criteria

I am a healthy adult between 18 and 39 years old and not pregnant or breastfeeding.

Must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified.

Exclusion Criteria

I sleep between 6-9 hours nightly and keep a regular sleep schedule.

You must have a social security number or tax identification number in order to be paid for screening and participation in the study

I am not on any medications that would exclude me from this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Sleep Deprivation

Participants undergo 40 hours of sleep deprivation

2 days

Recovery Sleep

Participants receive either acoustic stimulation or sham during a four-hour recovery sleep period over two nights

2 days

Follow-up

Participants are monitored for performance and mood using various tests and scales

5 days

What Are the Treatments Tested in This Trial?

Interventions

• Philips SmartSleep Acoustic Stimulation Device
• Sham (no Acoustic Stimulation)

Trial Overview The study tests if the Philips SmartSleep Acoustic Stimulation Device can improve recovery during sleep after being deprived of it. Participants will either receive this acoustic stimulation or a sham treatment with no sounds to compare effects on alertness and performance.

How Is the Trial Designed?

Group I: Subjects Who Received Acoustic Stimulation Experimental Treatment 1 Intervention

Following 40 hours of deprivation participants will sleep for approximately a four hour recovery sleep period and receive acoustic stimulation via the Philips SmartSleep during slow-wave sleep. They will then sleep for second night of four hour recovery sleep and receive acoustic stimulation via the Philips Smart Sleep device during slow-wave sleep again.

Group II: Subjects Who Received Sham (no Acoustic Stimulation) Placebo Group 1 Intervention

Following 40 hours of deprivation participants will sleep for approximately a four hour recovery sleep period and receive Sham (no acoustic stimulation) via the Philips SmartSleep during slow-wave sleep. They will then sleep for second night of four hour recovery sleep and receive Sham (no acoustic stimulation) via the Philips Smart Sleep device during slow-wave sleep again.

Philips SmartSleep Acoustic Stimulation Device is already approved in European Union, United States for the following indications:

Approved in European Union as Philips SmartSleep Wake-Up Light for:

• Sleep disorders
• Insomnia
• Circadian rhythm disorders

Approved in United States as Philips SmartSleep Wake-Up Light for:

• Sleep disorders
• Insomnia
• Circadian rhythm disorders

Who Is Running the Clinical Trial?

Walter Reed Army Institute of Research (WRAIR)

Lead Sponsor

Trials

111

Recruited

108,000+

Philips Healthcare

Industry Sponsor

Trials

127

Recruited

200,000+

Roy Jakobs

Philips Healthcare

Chief Executive Officer since 2022

Master's in Business Administration from Radboud University Nijmegen and Università degli Studi di Bologna

Dr. Roy Jakobs

Philips Healthcare

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

The iSleep system, which combines EEG monitoring and audio stimulation, significantly reduces the time it takes for individuals with slow sleep onset to fall asleep, as shown in a study with 28 healthy participants.

The closed-loop design of iSleep optimizes audio playback based on real-time brain activity, suggesting a promising approach to enhance sleep quality through tailored audio stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in time-to-sleep through EEG based brain state detection and audio stimulation. Zhuo Zhang, ., Cuntai Guan, ., Ti Eu Chan, ., et al.[2020]

The study compares four cases of patients who developed delirium with those who did not, focusing on their sleep patterns, light exposure, and sound levels.

Findings suggest that light and sound stimuli may influence the frequency of awakenings from sleep, potentially impacting the development of delirium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case studies: is the sleep of hospitalized elders related to delirium? Missildine, K., Bergstrom, N., Meininger, J., et al.[2010]

A biometrics-integrated lighting system was tested in the ICU to reduce light-induced sleep disturbances, aiming to improve patient sleep quality during hospitalization.

Preliminary results suggest that this lighting system could enhance patient satisfaction and reduce care costs, although further testing is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalography Data-Driven Lighting System to Improve Sleep Quality in Intensive Care Unit Patients: A Case Study. Koh, AP., van Schie, T., Park, Y., et al.[2020]

In male Wistar rats, auditory stimulation (ADS) significantly increased REM sleep by about 70% in undeprived animals, demonstrating its efficacy in enhancing REM sleep.

However, the study found no additional benefit of combining ADS with varying durations of REM sleep deprivation, suggesting that prior deprivation may alter brain excitability in a way that limits further enhancement from ADS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of auditory stimulation during recovery after REM sleep deprivation. Salín-Pascual, RJ., Jiménez-Anguiano, A., Durán-Vazquez, A., et al.[2019]

A new consumer device that uses EEG to detect sleep stages and deliver auditory stimulation has been shown to significantly enhance slow-wave activity (SWA) during sleep, with an average increase of 45.8% in 19 out of 22 participants.

This closed-loop system provides a novel approach to improving sleep quality, which could have beneficial effects on cognitive and metabolic functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid in-phase and continuous auditory stimulation significantly enhances slow wave activity during sleep. Garcia-Molina, G., Tsoneva, T., Neff, A., et al.[2020]

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]

This phase 1 study involving 11 adults with mild to moderate Alzheimer's disease demonstrated that targeted acoustic stimulation significantly increased slow-wave sleep (SWS), nearly doubling the time spent in this crucial sleep stage.

The use of the DREEM 2 headband for real-time sleep stage scoring showed promising feasibility for enhancing SWS in Alzheimer's patients, suggesting that further research in larger trials could optimize this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acoustic stimulation as a promising technique to enhance slow-wave sleep in Alzheimer's disease: results of a pilot study. Van den Bulcke, L., Peeters, AM., Heremans, E., et al.[2023]

An EEG closed-loop system was developed that effectively enhances slow-wave sleep using auditory stimulation, achieving 74% sensitivity and 97% specificity in detecting slow-wave sleep during a study with 28 participants over ten nights.

The system significantly increased slow-wave activity by 16.1% in younger participants, while older participants showed no effect, likely due to receiving less stimulation and age-related changes in sleep architecture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-loop system to enhance slow-wave activity. Garcia-Molina, G., Tsoneva, T., Jasko, J., et al.[2019]

The proposed closed-loop auditory stimulation system, which uses machine learning for real-time sleep stage tracking, effectively regulates sleep by driving EEG slow oscillations in ten subjects, showing immediate modulation effects after stimulation.

This new system demonstrated greater reliability and flexibility compared to existing methods, achieving consistent results across almost all participants in the experiment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A system based on machine learning for improving sleep. Lu, J., Yan, M., Wang, Q., et al.[2023]

In a study involving 24 3xTgAD mice, acoustic stimulation during sleep improved spatial memory and brain blood flow, suggesting it may help counteract the negative effects of chronic sleep deprivation associated with Alzheimer's disease.

Both the normal sleep and acoustic stimulation groups showed reduced amyloid β and tau pathology compared to the sleep deprivation group, indicating that acoustic stimulation could mimic the benefits of normal sleep patterns in Alzheimer's pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acoustic Stimulation Improves Memory and Reverses the Contribution of Chronic Sleep Deprivation to Pathology in 3xTgAD Mice. Liu, S., Lei, Q., Liu, Y., et al.[2022]

Citations

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

Reduction in time-to-sleep through EEG based brain state detection and audio stimulation. [2020]

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

Case studies: is the sleep of hospitalized elders related to delirium? [2010]

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

Electroencephalography Data-Driven Lighting System to Improve Sleep Quality in Intensive Care Unit Patients: A Case Study. [2020]

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

Administration of auditory stimulation during recovery after REM sleep deprivation. [2019]

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

Hybrid in-phase and continuous auditory stimulation significantly enhances slow wave activity during sleep. [2020]

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

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

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

Acoustic stimulation as a promising technique to enhance slow-wave sleep in Alzheimer's disease: results of a pilot study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Closed-loop system to enhance slow-wave activity. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A system based on machine learning for improving sleep. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Acoustic Stimulation Improves Memory and Reverses the Contribution of Chronic Sleep Deprivation to Pathology in 3xTgAD Mice. [2022]