Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults
Condition: Sleep
Study type: Interventional

Summary: 
      This study aims to assess whether slow wave sleep enhancement using SmartSleep technology
      benefits daytime cognitive performance during periods of chronic sleep restriction.
    

Detailed description: 
      Adequate healthy sleep is essential in spaceflight to ensure that astronauts maintain a high
      level of cognitive performance capability and do so without undue stress. There is a need for
      a technology that can improve sleep quality in space and biologically maximize the
      performance benefits of limited sleep duration, without unduly affecting the ability of
      astronauts to awaken abruptly and respond to an in-flight emergency. Sleep slow waves support
      system and synaptic consolidation by promoting specific patterns of neuromodulatory and
      electric activities, and subjective sleep quality is related to the size and number of slow
      waves that occur nightly.

      This study will use SmartSleep (Philips) technology to determine what effect the device has
      on daytime cognitive performance after emergent awakenings from sleep in a chronic sleep
      restriction paradigm. The SmartSleep technology uses two small sensors in the headband to
      continuously detect the brain's slow wave sleep (delta/theta frequency) in real time, and a
      closed-loop algorithm customizes the timing and volume of tones to optimize the sleep
      pattern. Thus, the device uses "quiet audio tones" (sub-awareness) to increase slow waves,
      which can enhance sleep quality/depth, thereby enhancing subsequent waking cognitive
      performance without the unwanted sedating effects of medications on cognitive functions
      during emergency awakenings.

      Subjects will be in the laboratory for 7 days/6 nights. Night 1 will be an adaptation night
      with 8-hours time in bed. Nights 2-5 will consist of 5 hours time in bed, followed by night 6
      of a recovery 10 hours time in bed. During nights 2-5, subjects will receive one of four
      stimulation modalities using the SmartSleep wearable device. Subjects will receive all four
      modalities in a randomized order:

        1. Continuous Fixed Interval

        2. Block

        3. In-Phase Adjustable

        4. Sham: No auditory stimulation while wearing the SmartSleep headband

      Cognitive performance testing and self-report surveys will be completed on a daily basis. A
      total of 12 healthy astronaut-like adults will be studied. Subjects will complete the 7-day
      study in groups of 4.
    

Intervention name(s): Philips SmartSleep Technology--Continuous Fixed Interval modality; Philips SmartSleep Technology--Block modality; Philips SmartSleep Technology--In-Phase Adjustable modality
Intervention type(s): Device; Device; Device
Intervention description(s): During the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities:
Continuous Fixed Interval
Block
In-Phase Adjustable
Sham: No auditory stimulation while wearing the SmartSleep headband; During the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities:
Continuous Fixed Interval
Block
In-Phase Adjustable
Sham: No auditory stimulation while wearing the SmartSleep headband; During the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities:
Continuous Fixed Interval
Block
In-Phase Adjustable
Sham: No auditory stimulation while wearing the SmartSleep headband
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study uses within subject randomization. Each subject will receive all of the 4 sleep conditions in a randomized order that will be unknown to the subject.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Sleep; Sleep restriction; Cognitive performance