Slow-wave Enhancement in Adults Aged 30-49

NCT04611828 | Completed

• 3 other identifiers: 2015-0337 Sub-Study 2A538900SMPH\PSYCHIATRY\PSYCHIATRY
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Keywords

sleep; cognitive performance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Global Cognition Battery Score per Stimulation Condition

  up to 8 weeks

• Karolinska Sleepiness Scale Score

  up to 8 weeks

Study Arms (1)

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): * continuous fixed interval (ITI): SmartSleep will provide 1 Hz, inter-tone interval stimulation continuous during deep sleep opportunities * block: SmartSleep will provide 5s ON versus 5s OFF,1Hz inter-tone interval stimulation * in-phase adjustable: SmartSleep will provide constant stimulation with tones timed to be delivered during each upstate of the slow wave 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

Device: Philips SmartSleep

Interventions

Philips SmartSleep DEVICE

closed-loop auditory stimulation

Philips SmartSleep Device

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide written informed consent
• Able to understand and speak English
• Left or right-handed participants may be included
• Participants have access to a cell phone that can receive text message reminders from study staff
• Participants have self-reported sleep latency (time taken to fall asleep) \> 30 minutes no more than once per week
• Participants have self-reported wake time after sleep onset ≤ 30 minutes
• Participants with Body Mass Index (BMI) \< 35 kg/m2 AND
• Participants self-report using an alarm to wake up ≥ 5 days a week
• Participants self-report sleeping one or more hours longer on weekends (or when given the opportunity) than they do on a typical work night

You may not qualify if:

• Participants who self-report taking medications that could affect sleep patterns
• Participants who have had travel in the last 2 weeks or who intend to travel during the experimental weeks with time zone shifts \>3h
• Participants unlikely to comply with the protocol (e.g., uncooperative attitude)
• Individuals who self-report a current severe or chronic medical condition or sleep disorder that may affect sleep patterns
• Individuals who self-report a history of recurrent seizures or epilepsy or family history of hereditary epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion)
• Participants who report not being consistent in their daily use of alcohol, caffeine, or nicotine
• Participants who are pregnant
• Participants who are night shift workers
• Individuals who self-report severe contact dermatitis or allergy to silicone, nickel or silver
• Individuals who self-report moderate hearing loss
• Self-reported history of excessive alcohol intake- selfreport \> 21 drinks / wk or binge alcohol consumption ( \>5 drinks per day)
• Excessive caffeine consumption (\> 7 cups) combining all caffeinated drinks regularly absorbed during workdays. Caffeine intake must be regular and maintained throughout study and on testing days
• Participants who do not have internet access at home
• Participants who express unwillingness to forego napping on weekdays during the study
• Participants who smoke

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Aeronautics and Space Administration (NASA): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53719, United States

Location

Study Officials

• Giulio Tononi, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be blind to the device condition
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: September 16, 2019
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)