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| Name | Class |
|---|---|
| National Aeronautics and Space Administration (NASA) | FED |
| Philips Healthcare | INDUSTRY |
| University of Wisconsin, Madison | OTHER |
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This study aims to assess whether slow wave sleep enhancement using SmartSleep technology benefits daytime cognitive performance during periods of chronic sleep restriction.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartSleep Continuous Fixed Interval modality | Experimental | This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition. This study arm tests the SmartSleep Continuous Fixed Interval stimulation modality during sleep relative to the SHAM condition. The Continuous Fixed Interval is the delivery of auditory tones a 1 Hz inter-tone interval stimulation. |
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| SmartSleep Block modality | Experimental | This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition. This study arm tests the SmartSleep Block stimulation modality during sleep relative to the SHAM condition. The Block is the delivery of auditory tones for 5 seconds on versus 5 seconds off. |
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| SmartSleep In-Phase Adjustable modality | Experimental | This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition. This study arm tests the SmartSleep In-Phase Adjustable stimulation modality during sleep relative to the SHAM condition. The In-Phase Adjustable is the constant stimulation with auditory tones delivered during each upstate of the slow wave. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips SmartSleep Technology--Continuous Fixed Interval modality | Device | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Slow-wave Activity | Total delta power measured during sleep | Days 3-6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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There are no pre-assignment events to report.
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| ID | Title | Description |
|---|---|---|
| FG000 | SmartSleep Stimulus Modality | This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Please refer to the attached study design and protocol for additional information. Philips SmartSleep Technology: 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:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 29, 2022 |
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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.
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The SmartSleep device will be programmed by investigators not involved in study execution. Subjects will wear the SmartSleep device each night and will be unaware of the order of stimulation modalities. In addition, both study personnel and those assessing outcomes will not be aware of the order of stimulation modalities.
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| SHAM condition | Sham Comparator | This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition. This study arm is the SHAM condition, during which participants wore the SmartSleep device, however no auditory tones were delivered. |
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| Philips SmartSleep Technology--Block modality | Device | 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:
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| Philips SmartSleep Technology--In-Phase Adjustable modality | Device | 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:
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| Days 3-6 |
| 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 |
| 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 |
| Continuous Fixed Interval | Each participant will receive the SmartSleep Continuous fixed interval modality during one night of sleep restriction |
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| Block | Each participant will receive the SmartSleep Block modality during one night of sleep restriction |
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| In-Phase Adjustable | Each participant will receive the SmartSleep In-Phase Adjustable modality during one night of sleep restriction |
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| SHAM | Each participant will receive the SmartSleep SHAM modality during one night of sleep restriction |
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| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population only includes participants who completed the study. A total of N=9 participants initiated the study, however one participant withdrew from the study, and therefore, the baseline analysis includes only participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | SmartSleep Modality Assignment | This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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:
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| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| PVT lapses of attention | This study-specific baseline measure is the average number of PVT lapses, a measure of vigilant attention, on the baseline day following the 8-hour adaptation night of the study (night 1). The number of lapses of attention were measured by the PVT-B and a lapse of attention was defined as a response time >355 ms. | Mean | Standard Deviation | PVT lapses |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | PVT lapses | Days 3-6 |
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| Primary | Slow-wave Activity | Total delta power measured during sleep | Posted | Mean | Standard Deviation | microvolts^2 | Days 3-6 |
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| 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. | Posted | Mean | Standard Deviation | Correct responses | Days 3-6 |
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| 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. | Posted | Mean | Standard Deviation | Correct responses | Days 3-6 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Days 3-6 |
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Adverse event data were collected throughout the duration of the study, which included study days 1-7
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SmartSleep Continuous Fixed Interval Modality | This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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:
This study arm tests the SmartSleep Continuous Fixed Interval stimulation modality during sleep. The Continuous Fixed Interval is the delivery of auditory tones a 1 Hz inter-tone interval stimulation. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | SmartSleep Block Modality | This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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:
This study arm tests the SmartSleep Block stimulation modality during sleep. The Block is the delivery of auditory tones for 5 seconds on versus 5 seconds off. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | SmartSleep In-Phase Adjustable Modality | This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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:
This study arm tests the SmartSleep In-Phase Adjustable stimulation modality during sleep. The In-Phase Adjustable is the constant stimulation with auditory tones delivered during each upstate of the slow wave. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | SHAM Condition | This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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:
This study arm is the SHAM condition, during which participants wore the SmartSleep device, however no auditory tones were delivered. | 0 | 8 | 0 | 8 | 0 | 8 |
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The primary limitation of this study is the small sample size and given the small sample, caution in interpreting the results is warranted.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Dinges | University of Pennsylvania | 215-898-9665 | dinges@pennmedicine.upenn.edu |
| Aug 29, 2022 |
| Prot_SAP_ICF_001.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
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| Sham |
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| Number of lapses of attention upon emergent awakening | Mixed Models Analysis | 0.49 | Mean Difference (Net) | -0.307 | Standard Error of the Mean | 0.441 | 2-Sided | 95 | -1.222 | 0.608 | Other | Linear mixed effects model with a random subject intercept. |
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