Slow-wave Enhancement in Adults Aged 30-49

Sleep Clinical Trial

Official title: Optimizing Peripheral Sensory Stimulation to Induce Sleep Slow Waves

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Sleep

• NCT number: NCT04611828
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Completion date: December 4, 2020