Philips SmartSleep Acoustic Stimulation Device for Sleep Deprivation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sleep Deprivation+4 MorePhilips SmartSleep Acoustic Stimulation Device - Device
Eligibility
18 - 39
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if sounds during sleep can help people who are sleep deprived perform better when awake.

Eligible Conditions
  • Sleep Deprivation
  • Alertness
  • Performance Anxiety
  • Acoustic Stimulation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 22 days

22 days
Measure various aspects of Sleep and Wakefulness using Actigraphy
5 days
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)
Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)
Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video
Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery
8 days
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Subjects Who Received Acoustic Stimulation
1 of 2
Subjects Who Received Sham (no Acoustic Stimulation)
1 of 2

Experimental Treatment

Non-Treatment Group

44 Total Participants · 2 Treatment Groups

Primary Treatment: Philips SmartSleep Acoustic Stimulation Device · Has Placebo Group · N/A

Subjects Who Received Acoustic Stimulation
Device
Experimental Group · 1 Intervention: Philips SmartSleep Acoustic Stimulation Device · Intervention Types: Device
Subjects Who Received Sham (no Acoustic Stimulation)
Device
ShamComparator Group · 1 Intervention: Sham (no Acoustic Stimulation) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 22 days

Who is running the clinical trial?

Philips HealthcareIndustry Sponsor
118 Previous Clinical Trials
278,638 Total Patients Enrolled
1 Trials studying Sleep Deprivation
202 Patients Enrolled for Sleep Deprivation
Walter Reed Army Institute of Research (WRAIR)Lead Sponsor
103 Previous Clinical Trials
36,541 Total Patients Enrolled
3 Trials studying Sleep Deprivation
142 Patients Enrolled for Sleep Deprivation

Eligibility Criteria

Age 18 - 39 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a healthy, non-pregnant, non-lactating woman.

Who else is applying?

What state do they live in?
Maryland100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Walter Reed Army Institute of Research100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%