Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity
Key facts
- Who runs it
- Christoph Nissen
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 60 people enrolled
- Started
- 1 Nov 2021
- Ended
- 14 Feb 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- Auditory closed-loop stimulation: slow oscillation boosting
- Auditory closed-loop stimulation: slow oscillation disruption
- Sham stimulation
- Record updated
- 4 March 2024
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- For patients: diagnosis of ID according to DSM 5 criteria; for controls: mentally and somatically healthy
- Age 18 to 65 years
- Written informed consent
Who cannot take part
- Intake of CNS active medication (except appropriate thyroid hormone substitution)
- 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)
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Patients with insomniaTreatment being tested
Patients with insomnia disorder according to DSM-5 criteria
Treatment: Auditory closed-loop stimulation: slow oscillation boosting, Auditory closed-loop stimulation: slow oscillation disruption, and Sham stimulation
- Healthy controlsTreatment being tested
Treatment: Auditory closed-loop stimulation: slow oscillation boosting, Auditory closed-loop stimulation: slow oscillation disruption, and Sham stimulation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 March 2024