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Completed

NCT Number: NCT04276064

Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity

Sleep is ubiquitous in animals and humans, and disruptions are of high clinical importance. Still, the neural basis of sleep perception is insufficiently understood, which limits the development of new treatments. The current project is designed to further contribute to the understanding of the neural basis of sleep perception and to the development of innovative treatments for disrupted sleep (insomnia).

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Key information

Conditions

Sleep Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • For patients: diagnosis of ID according to DSM 5 criteria; for controls: mentally and somatically healthy
  • Age 18 to 65 years
  • Written informed consent

Exclusion criteria

  • Relevant current or past serious medical disorder, including but not limited to cardiac arrhythmia, diabetes mellitus, and chronic pain conditions.
  • Neurological conditions including epilepsy, history of brain injury, encephalitis or any organic brain syndrome
  • Current or past mental disorders (life time prevalence), e.g. depressive disorder, attention deficit disorder, psychotic disorders, anxiety disorder, posttraumatic stress disorder
  • Sleep disorders (except ID for patients), including movement-related sleep disorders (PLMS index with arousal > 5) or breathing-related sleep disorders (AHI > 15)
  • Intake of CNS active medication (except appropriate thyroid hormone substitution)
  • Current or past substance abuse or dependency
  • Smoking > 5 cigarettes per day
  • Excessive caffeine consumption (> 500 mg or 5 cups coffee per day)
  • Irregular sleep schedules resulting from shift work, travelling or personal habits, defined as a sleep/wake time deviation > 4 hours in the weekly routine or as a habitual total sleep time < 4.5 hours or > 10 hours per night
  • Known pregnancy

Treatment and study plan

Auditory closed-loop stimulation: slow oscillation boosting

Device

Auditory-closed loop stimulation: slow oscillation boosting

Auditory closed-loop stimulation: slow oscillation disruption

Device

Auditory closed-loop stimulation: slow oscillation disruption

Sham stimulation

Device

Sham stimulation

Primary outcomes

  1. Modulation Index

    Time frame: Averaged across NREM sleep of the baseline night (about 6 hours)

    Measure of phase-amplitude coupling

Sponsors and collaborators

Lead sponsor

Christoph Nissen

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2020
Registry last updated
Mar 4, 2024

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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