Enhancing Sleep Slow Waves Using External Stimuli

NCT ID: NCT03323814

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-01
• Study Completion Date: 2019-06-13

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

Detailed Description

This is a single-site,unblinded study at the University of Wisconsin to determine the effectiveness of various stimulation modalities and parameters to maximize effectiveness for increasing slow waves during both nocturnal sleep and during daytime naps The ongoing study is a necessary exploratory step towards the future development of non-pharmacological means to improve sleep by increasing SWA.

Several different stimulation modalities will be examined including: auditory (soft tones delivered to the subject through earphones); somatosensory (brief and painless electrical pulses delivered to the median nerve through electrodes placed at the wrist); vestibular (brief and painless electrical pulses delivered through electrodes placed near the mastoids); olfactory (light puffs of air, with or without mild odorants, delivered to the nostril(s) and/or mouth; visual (brief light flashes via strobe light). The amplitude (stimulus intensity) and frequency (number of stimuli per unit time) of stimulation presentation will be systematically varied to identify the ideal parameters for slow wave induction during sleep. For each stimulation modality and each subject, we will determine the range of stimulus intensity from the minimum level sufficient for perceptual response (e.g. - the lowest volume setting for an auditory stimulus that the subject can hear) to a stimulus level that the subject deems comfortable to still allow sleep. This is particularly important, as sleep maintenance during these experiments requires stimulus intensity low enough to avoid awakening the subject. Additionally, based on previous results from our laboratory, the effective range of stimulus intensity will vary substantially between subjects - both the identified range during wakefulness, as well as the range that induces slow waves but avoids waking during the sleep recording. Given this response variability, during the sleep recordings stimulus intensity will be adjusted, starting with the range determined in waking, to find the optimal intensity to inducing sleep slow waves (based on EEG response patterns), and avoiding subject awakening.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Slow-wave optimization

Intervention Type: DEVICE

employing sensory stimulation to enhance slow waves

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.

Slow-wave optimization

Intervention Type: DEVICE

employing sensory stimulation to enhance slow waves

normal-sleepers

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

Slow-wave optimization

Intervention Type: DEVICE

employing sensory stimulation to enhance slow waves

Interventions

Slow-wave optimization

employing sensory stimulation to enhance slow waves

Intervention Type: DEVICE

Other Intervention Names

enhancing slow waves during non-rapid eye movement sleep

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guilio Tononi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

A538900

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\PSYCHIATRY\PSYCHIATRY

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0337 (H-2009-0052)

Identifier Type: -

Identifier Source: org_study_id