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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
Must not have
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
Women must not be pregnant or nursing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 days
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have, nor have I had, any sleeping problems like insomnia or sleep apnea.
Select...
I am not pregnant or breastfeeding.
Select...
I do not have a history of major heart, lung, kidney, liver diseases, serious mental health issues, or neurological disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 22 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
Secondary study objectives
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
36,730 Total Patients Enrolled
3 Trials studying Sleep Deprivation
142 Patients Enrolled for Sleep Deprivation
Philips HealthcareIndustry Sponsor
126 Previous Clinical Trials
199,971 Total Patients Enrolled
1 Trials studying Sleep Deprivation
202 Patients Enrolled for Sleep Deprivation
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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.
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