Status:
COMPLETED
Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity
Lead Sponsor:
Christoph Nissen
Conditions:
Sleep
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ne...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04276064
Start Date
November 1 2021
End Date
February 14 2024
Last Update
March 4 2024
Active Locations (1)
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1
University of Bern
Bern, Switzerland