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

Christoph Nissen

Status: Completed

Conditions: Insomnia; Sleep

Treatments: Device: Auditory closed-loop stimulation: slow oscillation boosting; Device: Sham stimulation; Device: Auditory closed-loop stimulation: slow oscillation disruption

Study type: Interventional

Funder types: Other

Identifiers

NCT04276064

2019-02426

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Patients with insomnia

Experimental group

Description:

Patients with insomnia disorder according to DSM-5 criteria

Treatment:

Device: Sham stimulation

Device: Auditory closed-loop stimulation: slow oscillation boosting

Device: Auditory closed-loop stimulation: slow oscillation disruption

Healthy controls

Experimental group

Description:

Healthy controls

Treatment:

Device: Sham stimulation

Device: Auditory closed-loop stimulation: slow oscillation boosting

Device: Auditory closed-loop stimulation: slow oscillation disruption