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| ID | Type | Description | Link |
|---|---|---|---|
| A538900 | Other Identifier | UW Madison | |
| SMPH\PSYCHIATRY\PSYCHIATRY | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Aeronautics and Space Administration (NASA) | FED |
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A single-site, randomized study to assess the effectiveness of different types of closed-loop auditory stimulation on slow-wave enhancement using SmartSleep in an astronaut-like sample of adults between the ages of 30 and 55. Secondary analyses will be performed to determine whether slow-wave enhancement influences neurobehavioral performance in this population. Participants will be on study for 8 weeks.
The investigators seek to determine the extent to which various closed-loop auditory stimulation protocols (continuous fixed interval, block, in-phase adjustable) differentially affect slow-wave sleep. Participants will run the study for eight weeks, which includes wearing the SmartSleep device nightly, and completing one 3-min and one 20-min cognitive assessment battery each day, as well as computerized post-sleep questionnaires each morning, sleepiness scales three times a day, and a weekly evaluation of device comfort. This study will employ various types of auditory stimulation in order to determine 1) which stimulation pattern is maximally effective at enhancing slow wave activity (SWA) and 2) to assess cognitive performance associated with each stimulation algorithm. The study requires a longer duration so that sufficient data on each distinct type of stimulation may be collected.
Participants will be instructed to wear the SmartSleep device at home for three two-week periods, and will complete 10 nights per period of continuous fixed interval, block, or in-phase adjustable stimulation (in randomized order). Between each of these periods, participants will complete one week of sham condition (this condition records sleep EEG without any stimulation and is used to define each participant's typical sleep). During all eight weeks, participants will complete a 20-minute cognitive assessment in the evening, a five-minute cognitive assessment in the morning, and respond to the Karolinska Sleepiness Scale three times per day. The cognitive assessments will be accompanied by short questionnaires. Participants will receive text message reminders from study staff when it is time to perform these assessments.
Primary objective: Determine which stimulation type (e.g., Block stimulation, Fixed ITI, in-phase) is most effective at enhancing slow-waves slow-wave sleep relative to baseline sleep in a group of astronaut-like subjects in an ecologically valid setting.
Main secondary objective: Determine the extent to which various closed-loop auditory stimulation protocols (continuous fixed interval, block, inphase adjustable) differentially affect various aspects of neurobehavioral function using a set validated cognitive tasks as part of the Cognition battery.
Other secondary objectives: Explore the relationships between improvements in SWA and measures of subjective sleepiness as assessed by the Karolinska Sleepiness Scale
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Philips SmartSleep Device | Experimental | Participants will be instructed to sleep wearing the SmartSleep device at home for eight weeks, which will include three (3) two-week periods, one each of the following (in randomized order):
Between periods 1 and 2 and between periods 2 and 3, subjects will undergo one week of sham condition during which SmartSleep will record EEG during sleep using a no-volume sham stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips SmartSleep | Device | closed-loop auditory stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Slow Wave Activity between Audio Stimulation Condition and Sham Condition | To compare the three different types of stimulation, a common outcome was selected which is the change in slowwave activity between periods where the stimulation is applied versus equivalent periods, in a sham condition, where the stimulation is not applied but would have been applied. Three different conditions defined in the arm description will be measured: continuous fixed interval, block, and in-phase adjustable; each compared to the sham condition. Participant is blinded to each condition; all data collected over 8 weeks. | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Cognition Battery Score per Stimulation Condition | Cognition is a brief electronic battery that assesses several domains of cognitive function including attention, executive function, reaction time, short-term memory, working memory, spatial ability, and risk taking. Performance will be assessed under each stimulation condition and sham to determine whether enhancement impacts global performance. Total range of possible scores 10-100 where higher scores indicate increased cognition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giulio Tononi, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53719 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 2, 2020 | Jan 25, 2021 | ICF_000.pdf |
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Participants will be blind to the device condition
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| up to 8 weeks |
| Karolinska Sleepiness Scale Score | These scales will be analyzed for changes in subjective sleepiness and perceived sleep quality between periods of different types of auditory stimulation and sham condition. Participants will be assessed 3 times daily (morning, afternoon, and evening), they will rate their alertness on a scale of 1 (extremely alert) to 9 (extremely sleepy, fighting sleep). | up to 8 weeks |