Acoustic Stimulation for Sleep Deprivation
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Walter Reed Army Institute of Research (WRAIR)
Disqualifiers: Cardiovascular, Neurologic, Pulmonary, Kidney, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
15678How 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.
147910Eligibility Criteria
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.
+8 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Subjects Who Received Acoustic StimulationExperimental Treatment1 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 Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Walter Reed Army Institute of ResearchSilver Spring, MD
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Who Is Running the Clinical Trial?
Walter Reed Army Institute of Research (WRAIR)Lead Sponsor
Philips HealthcareIndustry Sponsor
References
Reduction in time-to-sleep through EEG based brain state detection and audio stimulation. [2020]We developed an EEG- and audio-based sleep sensing and enhancing system, called iSleep (interactive Sleep enhancement apparatus). The system adopts a closed-loop approach which optimizes the audio recording selection based on user's sleep status detected through our online EEG computing algorithm. The iSleep prototype comprises two major parts: 1) a sleeping mask integrated with a single channel EEG electrode and amplifier, a pair of stereo earphones and a microcontroller with wireless circuit for control and data streaming; 2) a mobile app to receive EEG signals for online sleep monitoring and audio playback control. In this study we attempt to validate our hypothesis that appropriate audio stimulation in relation to brain state can induce faster onset of sleep and improve the quality of a nap. We conduct experiments on 28 healthy subjects, each undergoing two nap sessions - one with a quiet background and one with our audio-stimulation. We compare the time-to-sleep in both sessions between two groups of subjects, e.g., fast and slow sleep onset groups. The p-value obtained from Wilcoxon Signed Rank Test is 1.22e-04 for slow onset group, which demonstrates that iSleep can significantly reduce the time-to-sleep for people with difficulty in falling sleep.
Case studies: is the sleep of hospitalized elders related to delirium? [2010]Four cases are presented to compare sleep, light, and sound levels of patients who developed delirium to patients who did not develop delirium, and to determine the effect of light and sound stimuli upon awakenings from sleep.
Electroencephalography Data-Driven Lighting System to Improve Sleep Quality in Intensive Care Unit Patients: A Case Study. [2020]Sleep disturbance and deprivation are major factors in delayed recovery, which can affect both the physical and emotional well-being of patients. Patients hospitalized in the Intensive Care Unit (ICU) are especially vulnerable to sleep deprivation due to light-induced disturbances. A desirable lighting intervention in the ICU would minimize light-induced disturbances while simultaneously providing feedback for the staff on when to perform patient care activities that require high intensity lighting. To this end, we performed a first phase testing for a biometrics-integrated lighting system that serves a dual function of sleep initiation and maintenance to improve the patient's quality of sleep. Preliminary findings are presented as a case study to assess the feasibility of scaling up the experimental model. While findings point to additional testing being necessary to determine whether the lighting system will be effective, the experiment detailed in this report establishes a starting paradigm upon which to base further investigation.Clinical Relevance- A biometrics-integrated lighting system that can improve sleep quality of the patient will not only reduce cost of care for the patients, but also increase the level of satisfaction for both patients and the hospital staff.
Administration of auditory stimulation during recovery after REM sleep deprivation. [2019]Rapid eye movement (REM) sleep deprivation and auditory stimulation (ADS), separately, increase REM sleep in rats, cats and humans. The main goal of the present study was to test whether administration of ADS during REM sleep rebound has a synergistic effect on REM sleep elicitation. Male Wistar rats were implanted with standard sleep recording electrodes. Following the recovery period, animals were randomly assigned to the following conditions: undeprived (i.e. control) and 24, 48, 96 and 120 hours of REM sleep deprivation by the platform method. Undeprived and REM sleep-deprived animals were divided into two groups, with and without ADS. ADS was a "beep" of 80 dB and 2,000 Hz, lasting 20 msec every 10 seconds. This stimulus was applied for the first 4 hours of sleep recordings after deprivation. After that, animals were recorded for another 4 hours. In the undeprived situation, the group that received ADS increased REM sleep approximately 70% above the group that did not receive ADS, as has been reported previously (REM sleep without ADS: 38.1 +/- 13.84 vs. with ADS: 64.6 +/- 11.8, p
Hybrid in-phase and continuous auditory stimulation significantly enhances slow wave activity during sleep. [2020]Recent evidence has shown that enhancing slow-wave activity (SWA) during sleep has positive effects on cognitive, metabolic, and autonomic function. We have developed a consumer, integrated device that automatically detects sleep stages from a single electroencephalogram (EEG) signal and delivers auditory stimulation in a closed-loop manner. The stimulation was delivered in 15-auditory tone blocks separated from each other by at least 15 seconds. The first tone in a block was synchronized to the up-state of a detected slow-wave while subsequent ones were separated from each other by a constant 1-second inter-tone interval. The system was tested in a study involving 22 participants and SWA enhancement (average 45.8%; p=0.0027) was found in 19/22 participants.
Updated Review of the Acoustic Modulation of Sleep: Current Perspectives and Emerging Concepts. [2021]With growing interest in the use of acoustic stimuli in sleep research and acoustic interventions used therapeutically for sleep enhancement, there is a need for an overview of the current lines of research. This paper summarizes the various ways to use acoustic input before sleep or stimulation during sleep. It thereby focuses on the respective methodological requirements, advantages, disadvantages, potentials and difficulties of acoustic sleep modulation. It highlights differences in subjective and objective outcome measures, immediate and whole night effects and short versus long term effects. This recognizes the fact that not all outcome parameters are relevant in every research field. The same applies to conclusions drawn from other outcome dimensions, consideration of mediating factors, levels of stimulation processing and the impact of inter-individual differences. In addition to the deliberate influences of acoustic input on sleep, one paragraph describes adverse environmental acoustic influences. Finally, the possibilities for clinical and basic research-related applications are discussed, and emerging opportunities are presented. This overview is not a systematic review but aims to present the current perspective and hence summarizes the most up-to-date research results and reviews. This is the first review providing a summary of the broad spectrum of possibilities to acoustically influence sleep.
Acoustic stimulation as a promising technique to enhance slow-wave sleep in Alzheimer's disease: results of a pilot study. [2023]Sleep disturbances are common in people with Alzheimer's disease (AD), and a reduction in slow-wave activity is the most striking underlying change. Acoustic stimulation has emerged as a promising approach to enhance slow-wave activity in healthy adults and people with amnestic mild cognitive impairment. In this phase 1 study we investigated, for the first time, the feasibility of acoustic stimulation in AD and piloted the effect on slow-wave sleep (SWS).
Closed-loop system to enhance slow-wave activity. [2019]Recent evidence reports cognitive, metabolic, and sleep restoration benefits resulting from the enhancement of sleep slow-waves using auditory stimulation. Our objective is to make this concept practical for consumer use by developing and validating an electroencephalogram (EEG) closed-loop system to deliver auditory stimulation during sleep to enhance slow-waves.
A system based on machine learning for improving sleep. [2023]Closed-loop auditory stimulation is one of the well-known and emerging sensory stimulation techniques, which achieves the purpose of sleep regulation by driving the EEG slow oscillation (SO,
Acoustic Stimulation Improves Memory and Reverses the Contribution of Chronic Sleep Deprivation to Pathology in 3xTgAD Mice. [2022]Acoustic stimulation during sleep is believed to enhance slow waves, which are critical to memory consolidation. However, clinical trials of acoustic stimulation have yielded mixed results concerning its effectiveness in improving human memory. A few studies have implied that acoustic stimulation ameliorates the pathology of Alzheimer's disease (AD) in mice with normal sleep. Here, we explored the effect of acoustic stimulation on 3xTgAD mice suffering from chronic sleep deprivation, as these data may shed light on the potential use of acoustic stimulation in AD patients with insomnia. Methods: Twenty-four 8-month-old 3xTgAD mice were randomly and equally divided into three groups: the normal sleep group (S group), the sleep deprivation group (SD group), and the acoustic stimulation group (AS group). During a 14-day sleep intervention, the SD and AS groups received 6 h of sleep deprivation per day, and the AS group also received acoustic stimulation in the dark phase. Then, the mice underwent Morris water maze (MWM) tests and arterial spin labelling (ASL) magnetic resonance imaging (MRI) scans and were sacrificed for pathological evaluation. Results: The three groups showed similar stress levels. The S and AS groups exhibited better spatial memory, better brain perfusion, and milder amyloid β (Aβ) and tau pathology than the SD group, although no significant discrepancies were found between the S and AS groups. Conclusion: Acoustic stimulation may exert a protective effect in 3xTgAD mice by improving spatial memory, enhancing the blood supply of the brain, and reversing the contribution of chronic sleep deprivation to Aβ and tau pathology to mimic the effect of normal sleep patterns.