Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults

Sleep Clinical Trial

Official title:

Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults in Order to Mitigate Cognitive Performance Deficits Due to Sleep Restriction and Emergency Awakenings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911154
• Other study ID #: NNX16AO69A/T0408
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• Bachelor's degree or Master's degree (or the equivalent in work experience) in a relevant field, and/or military service.

• Free of psychological/psychiatric conditions that preclude participation.

• BMI < 35.

• Self-reported regular sleep schedule; able to maintain their sleep schedule during the course of the study.

• Self-reported sleep duration of 6-8.5 hrs per night (verified by 6 work days of ambulatory sleep monitoring with wrist actigraphy and daily logs).

• Ability to read/write English.

Exclusion Criteria:

• History of neurological, psychiatric, or other medical condition that excludes participation.

• Current mania or psychosis.

• Current depression as determined by the Beck Depression Inventory (Beck, 1996).

• Alcohol or drug abuse in the past year based upon history and urine toxicology screen.

• Excessive alcohol intake (= 21 drinks per week) or binge alcohol consumption (> 5 drinks per day).

• Excessive caffeine consumption (> 650mg/day combining all caffeinated drinks regularly absorbed during the day).

• Current smoker/tobacco user, or using nicotine replacement therapy. Those that have been nicotine-free for 30 days will be included.

• Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness based on history, physical exam, blood and urine chemistries, and CBC.

• Individuals who self-report a history of recurrent seizures or epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).

• Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that exclude participation.

• Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, COPD, respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report).

• Currently working night, swing, split or rotating shift.

• Current use or use of within the past month of a prescription or over-the-counter sleep medication or stimulant; use of psychoactive medication (based on self-report and review with a study clinician).

• Pregnant or currently breast feeding

• Prior history or diagnosis of any sleep disorder

• High Risk of OSA based on STOP-BANG Questionnaire ("yes" on at least 4 of 8 questions)

• High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire

• High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher)

• Individuals who self-report severe contact dermatitis or allergy to silicone, nickel or silver.

• Individuals who self-report moderate hearing loss.

• Inability to achieve appropriate headband fit.

• Planned travel across more than one time zone one month prior to and/or during the anticipated period of the study with SmartSleeps device use.

• Intentional naps during the week.

Related Conditions & MeSH terms

• Sleep

Intervention

Device:
• Philips SmartSleep Technology--Continuous Fixed Interval modality
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
• Philips SmartSleep Technology--Block modality
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
• Philips SmartSleep Technology--In-Phase Adjustable modality
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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	National Aeronautics and Space Administration (NASA), Philips Healthcare, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychomotor Vigilance Test-Brief (PVT-B)	The PVT is a simple reaction time test that requires participants to react, as quickly as possible, by pressing a response key as soon as a rolling number counter presented in a box in the center of the computer screen appears. The PVT is a validated and widely-used measure of vigilant attention that is sensitive to the effects of sleep loss. The primary outcome was the number of PVT lapses. The minimum number of PVT lapses is "0" and there is no maximum number of lapses, which are defined as response times >355 ms. More PVT lapses indicates worse performance.	Days 3-6
Primary	Slow-wave Activity	Total delta power measured during sleep	Days 3-6
Secondary	Digit Symbol Substitution Test (DSST)	The Digit Symbol Substitution Test (DSST) is a widely used measure of cognitive throughput and cognitive instability that is sensitive to the effects of sleep loss. The DSST was adapted from the Wechsler Adult Intelligence Scale. Participants are shown an array of symbols and with corresponding numbers on a keyboard. They are then presented the symbols one at a time in random order and must respond with the correct corresponding number as quickly as possible. The primary outcome was number correct and given the established practice effects on the DSST, this measure was corrected for practice effects. The DSST has a minimum of "0" correct responses and does not have a maximum; a higher number on the DSST represents better performance.	Days 3-6
Secondary	Descending Subtraction Task (DST)	The Descending Subtraction Test (DST) is a measure of working memory that is sensitive to the effects of sleep loss. The DST requires participants to mentally subtract numbers in a sequential fashion as quickly as possible. For example, if the starting number is 987, the participant subtracts nine from 987, with the difference being 978, the participant then subtracts eight from 978, and so on subtracting by seven, six, five, four, three, two, and one, from each difference at which point, and the participant then recycles the subtraction sequence beginning at nine again. The DST has a minimum of "0" correct responses and does not have a maximum; a higher number on the DST represents better performance. The primary outcome on the DST was Number correct.	Days 3-6
Secondary	Robotic On-Board Trainer (ROBoT) Task	The Robotic On-Board Trainer (ROBoT) task is NASA's platform for training astronauts to perform docking and grappling maneuvers using the Canada Arm. The system is based on highly realistic 3D simulations of the arm and associated physics. The ROBoT system involves a left-hand translational controller (x/y/z directions) and a right-hand rotational controller (pitch/roll/yaw), plus two laptop computer screens. Key performance metrics include: (i) docking position accuracy, (ii) docking orientation accuracy, (iii) total task time, and (iv) smoothness of approach trajectory, which are aggregated to generate the primary outcome, which is the mean weighted score . The weighted score ranges from 0 to 10 and a lower score indicates better performance.	Days 3-6