Slow-wave Enhancement in Adults Aged 30-49
Completed · Not applicable
Conditions studied: Sleep
In brief
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.
Key facts
- Study ID
- NCT04611828
- Run by
- University of Wisconsin, Madison
- People needed
- 28
- Starts
- 2019-09-16
- Expected to finish
- 2020-12-04
- Last updated by the study team
- 2021-01-28
Who can join
Age: 30 and older, up to 49. Sex: any. Healthy volunteers: accepted.
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
- Participants with high risk of Obstructive Sleep Apnea (OSA) based on STOP-BANG Questionnaire ("yes" on at least 4 of 8 questions)
- High Risk of Restless Legs Syndrome (RLS) based on the short form Cambridge-Hopkins Screening questionnaire
- High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher)
Where it is running
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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