University of Wisconsin
Madison, Wisconsin, 53719, United States
NCT Number: NCT04611828
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.
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Notify Me30 year–49 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53719, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
closed-loop auditory stimulation
Time frame: up to 8 weeks
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.
Time frame: up to 8 weeks
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.
Time frame: up to 8 weeks
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).
University of Wisconsin, Madison
Other
Optimizing Peripheral Sensory Stimulation to Induce Sleep Slow Waves
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