Sleep DeprivationNCT05309473
Acoustic Stimulation During Restricted Sleep After Sleep Deprivation
A study testing Philips SmartSleep Acoustic Stimulation Device in people with Sleep Deprivation and Sleep Restriction, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep Restriction, Acoustic Stimulation
- What is being tested?
- Philips SmartSleep Acoustic Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to Oct 2026
- 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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
- 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.
Who cannot join
- You must have learned English as your first language
- You must have a body mass index (BMI) below 30 (this is a mathematical calculation of your height and weight)
- You must not have current or a history of sleeping problems (for example, insomnia or sleep apnea), or symptoms that indicate a potential sleep disorder
- You must get an average of 6-9 hours of sleep per night and maintain a normal sleep/wake schedule
- You must not drink excessive amounts of caffeine, alcohol, or smoke cigarettes regularly
- You must not be on certain medications (determined on a case by case basis)
Show all 11Show fewer
- You must test negative for illicit drugs
- Women must not be pregnant or nursing
- You must not be participating in another ongoing clinical trial
- You must have a social security number or tax identification number in order to be paid for screening and participation in the study
- You cannot have a history of the following conditions: Cardiovascular disease, a neurologic disorder, pulmonary disease requiring inhaler use, kidney disease or kidney abnormalities, liver disease of liver abnormalities, a history of psychiatric disorder requiring hospitalization or medication within the last two years or for a continuous period of more than 6 months in the last ten years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
Ruthie Ratcliffe, 301-319-3131, ruthie.h.ratcliffe.civ@mail.mil
Kajsa Carlsson, 301-319-9287, kajsa.e.carlsson.ctr@mail.mil
About this study
Official title: Slow-wave Sleep Enhancement Using Acoustic Stimulation to Facilitate Performance Recovery During Restricted Sleep After Sleep Deprivation
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.
- Being tested
- Philips SmartSleep Acoustic Stimulation Device, Sham (no Acoustic Stimulation)
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips SmartSleep Acoustic Stimulation DeviceDevice
Prior to bedtime on the first two recovery nights, a Philips SmartSleep device will be applied to the head of each subject. Subjects will receive acoustic stimulation during the four hours of sleep.
Sham (no Acoustic Stimulation)Device
Prior to bedtime on the first two recovery nights, a Philips SmartSleep device will be applied to the head of each subject. Subjects will receive Sham (no acoustic stimulation) during the four hours of sleep.
| Study group | Role | What they receive |
|---|---|---|
| Subjects Who Received Acoustic Stimulation | Experimental | 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. Receives: Device: Philips SmartSleep Acoustic Stimulation Device |
| Subjects Who Received Sham (no Acoustic Stimulation) | Sham comparator | 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. Receives: Device: Sham (no Acoustic Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
Performed at approximately 75 minutes intervals throughout the sleep deprivation and recovery days
Measured: 8 days
Secondary outcomes (7)
Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)
Computer based series of mathematical calculations
Measured: 5 days
Measure current mood states using the Mood Analogue Scale (MAS)
Computer based self adjective checklist of measure mood states
Measured: 5 days
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)
Subjects will be escorted to their individual darkened, sound-attenuated bedrooms and allowed to lie down on their beds. They will be instructed to close their eyes and try to remain awake. Polysomnography will be monitored online.
Measured: 5 days
Measure alertness using the Karolinska Sleepiness Scale (KSS)
Computer based self rated level of sleepiness
Measured: 5 days
Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery
Computer based battery testing various aspects of mood
Measured: 5 days
Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video
Sleep will be measured during the night using polysomnography
Measured: 5 days
Measure various aspects of Sleep and Wakefulness using Actigraphy
A watch-like device called an actigraph will measure movement to determine wake and sleep
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start14 Mar 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, JOHN D. HUGHES, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309473
- Sponsor's protocol ID
- 2901
- Status last verified
- Apr 2024
- First submitted
- 17 Feb 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow-wave Sleep Enhancement Using Acoustic Stimulation to Facilitate Performance Recovery During Restricted Sleep After Sleep Deprivation
- ClinicalTrials.gov ID
- NCT05309473
- Acronym / sponsor ID
- 2901
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Collaborators
- Philips Healthcare
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 Apr 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects Who Received Acoustic Stimulation | Experimental | Device: Philips SmartSleep Acoustic Stimulation DeviceFollowing 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. |
| Subjects Who Received Sham (no Acoustic Stimulation) | Sham comparator | Device: Sham (no Acoustic Stimulation)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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
- 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.
Key exclusion criteria (11 listed)
- You must have learned English as your first language
- You must have a body mass index (BMI) below 30 (this is a mathematical calculation of your height and weight)
- You must not have current or a history of sleeping problems (for example, insomnia or sleep apnea), or symptoms that indicate a potential sleep disorder
- You must get an average of 6-9 hours of sleep per night and maintain a normal sleep/wake schedule
- You must not drink excessive amounts of caffeine, alcohol, or smoke cigarettes regularly
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 |
|---|---|---|
| Philips SmartSleep Acoustic Stimulation DevicePrior to bedtime on the first two recovery nights, a Philips SmartSleep device will be applied to the head of each subject. Subjects will receive acoustic stimulation during the four hours of sleep. | Device | Subjects Who Received Acoustic Stimulation |
| Sham (no Acoustic Stimulation)Prior to bedtime on the first two recovery nights, a Philips SmartSleep device will be applied to the head of each subject. Subjects will receive Sham (no acoustic stimulation) during the four hours of sleep. | Device | Subjects Who Received Sham (no Acoustic Stimulation) |
Primary outcome
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
Time frame: 8 days
Performed at approximately 75 minutes intervals throughout the sleep deprivation and recovery days
7 secondary outcomes
Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)
Time frame: 5 days
Measure current mood states using the Mood Analogue Scale (MAS)
Time frame: 5 days
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)
Time frame: 5 days
Measure alertness using the Karolinska Sleepiness Scale (KSS)
Time frame: 5 days
Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery
Time frame: 5 days
Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video
Time frame: 5 days
Measure various aspects of Sleep and Wakefulness using Actigraphy
Time frame: 22 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
Related trials for Sleep Deprivation
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
The Function of Biphasic Sleep in Infants
Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips SmartSleep Acoustic Stimulation Device in people with Sleep Deprivation and Sleep Restriction, run by Walter Reed Army Institute of Research (WRAIR) 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John D Hughes, MD (301-319-3214, john.d.hughes4.ctr@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT) (time frame: 8 days). 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 23 Apr 2024.