Enhancing Sleep Slow Waves Using External Stimuli

NCT03323814 | Completed

• 3 other identifiers: 2015-0337 (H-2009-0052)A538900SMPH\PSYCHIATRY\PSYCHIATRY
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational study to determine if the presentation of sensory stimulation during sleep can increase slow-wave activity during non-rapid eye movement sleep

Conditions

Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization

Outcome Measures

Primary Outcomes (1)

• Enhancing slow-wave sleep

  increase slow-wave activity during non-rapid eye movement sleep

  10 years

Study Arms (3)

short-sleepers

subset of participants will be recruited who report less than typical work/ weekday sleep in order to examine whether enhancing sleep with stimulation will reduce the amount of extra sleep subjects usually get on the weekends.

Device: Slow-wave optimization

shift-workers

An additional subset of participants will be recruited who work evening shifts to see if enhanced sleep can counteract some of the effects of schedule shifting.

Device: Slow-wave optimization

normal-sleepers

The first cohort will be used to optimize the the type and duration of sensory stimuli that will optimally enhance slow-waves.

Device: Slow-wave optimization

Interventions

Slow-wave optimization DEVICE

employing sensory stimulation to enhance slow waves

Also known as: enhancing slow waves during non-rapid eye movement sleep

normal-sleepers; shift-workers; short-sleepers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 healthy volunteers will participatea)

You may qualify if:

• Able to understand and speak English;
• Left or right-handed subjects may be included.
• Age of ≥18 years and ≤ 75;
• Able to understand and speak English;
• Left or right-handed subjects may be included.
• Age of ≥18 years and ≤ 75;

You may not qualify if:

• Subjects taking medications that could affect sleep patterns (based on self-report and review with a study clinician).
• Subjects who have had travel in the last 2 weeks or who intend to travel during the 4 experimental weeks (for at-home subjects) with time zone shifts \>1h;
• The investigator anticipates that the subject will be unable to comply with the protocol.
• Individuals who self-report a current severe or chronic medical condition or sleep disorder that may affect sleep patterns (based on self-report and review with a study clinician).
• 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).
• Subjects who do report not being consistent in their daily use of alcohol, caffeine, or nicotine.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Philips Healthcare: collaborator

Study Officials

• Guilio Tononi, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: October 27, 2017
• Study Start: August 1, 2009
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share