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Behavioural Intervention
Acoustic Stimulation for Sleep Deprivation
N/A
Recruiting
Research Sponsored by Walter Reed Army Institute of Research (WRAIR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 days
Awards & highlights
Study Summary
This trial will test if sounds during sleep can help people who are sleep deprived perform better when awake.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves acoustic stimulation during sleep, potential side effects may include disturbances in sleep quality or patterns, headaches upon waking up, discomfort due to wearing the device, and possible irritation from sound exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult between 18 and 39 years old and not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 22 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
Secondary outcome measures
Measure alertness using the Karolinska Sleepiness Scale (KSS)
Measure current mood states using the Mood Analogue Scale (MAS)
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)
+4 moreTrial Design
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.
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Who is running the clinical trial?
Walter Reed Army Institute of Research (WRAIR)Lead Sponsor
107 Previous Clinical Trials
36,720 Total Patients Enrolled
3 Trials studying Sleep Deprivation
142 Patients Enrolled for Sleep Deprivation
Philips HealthcareIndustry Sponsor
125 Previous Clinical Trials
282,282 Total Patients Enrolled
1 Trials studying Sleep Deprivation
202 Patients Enrolled for Sleep Deprivation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I sleep between 6-9 hours nightly and keep a regular sleep schedule.I am a healthy adult between 18 and 39 years old and not pregnant or breastfeeding.I am not on any medications that would exclude me from this trial.I do not have, nor have I had, any sleeping problems like insomnia or sleep apnea.I am not pregnant or breastfeeding.I do not drink a lot of caffeine or alcohol, nor do I smoke regularly.I do not have a history of major heart, lung, kidney, liver diseases, serious mental health issues, or neurological disorders.Your weight in relation to your height must be within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects Who Received Sham (no Acoustic Stimulation)
- Group 2: Subjects Who Received Acoustic Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include minors as participants?
"This investigation abides by the stipulation that potential participants must be over 18 years of age and under 39."
Answered by AI
Are there any openings to enroll in this experiment?
"Affirmative. Clinicaltrials.gov's records show that this medical trial, which was first posted on March 14th 2022, is currently recruiting participants. There are 44 slots to be filled at a single clinical site."
Answered by AI
To whom is eligibility for this clinical investigation open?
"This trial seeks 44 participants aged between 18 and 39 suffering from sleep debt. To qualify, applicants must be men or non-pregnant, non-lactating women who pass a protocol comprehension quiz with 80% accuracy. Candidates are given one retest chance in the event of an initial failure before disqualification occurs."
Answered by AI
What is the enrollment count for this investigation?
"Affirmative, the information available on clinicaltrials.gov reveals that this trial is currently recruiting participants. It was originally posted on March 14th 2022 and has since been updated June 28th 2022. This study requires 44 volunteers from a single site to participate in it."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Maryland
How old are they?
18 - 65
What site did they apply to?
Walter Reed Army Institute of Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
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