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Completed

NCT Number: NCT04461769

Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.

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Key information

Conditions

Sleep Behavior Health Behavior Sleep Hygiene

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brain Electrophysiology Laboratory Company

Eugene, Oregon, 97405, United States

About this study

Previous studies have demonstrated successful synchronization of SOs with slow TES pulses. However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3, F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from frontal neocortex. In the present study, we hypothesized that transcranial electrical stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3 sleep. Furthermore, based on our computational modeling with this more optimal targeting of the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1 or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

  • history of seizures
  • epilepsy
  • brain trauma or injury
  • insomnia
  • sleep apnea
  • medications that may affect the EEG.

Treatment and study plan

Transcranial Electrical Stimulation

Device

Oscillating electrical current

Other names: Sleep WISP (Wireless Interface Sensor Pod)

Primary outcomes

  1. N3 Duration

    Time frame: Measured during the night of sleep (typically 8 hours)

    Duration in minutes of N3 sleep

Secondary outcomes

  1. N3 Percentage

    Time frame: Measured during the night of sleep (typically 8 hours)

    Percentage of the night's sleep spent in N3

Sponsors and collaborators

Lead sponsor

Brain Electrophysiology Laboratory Company

Industry

Registry information

Acronym: ESSOTEDS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2020
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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