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

Study Overview
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Brief Summary
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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).

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

Conditions
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Sleep, Insomnia

Intervention / Treatment
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* Device: Auditory closed-loop stimulation: slow oscillation boosting
* Device: Auditory closed-loop stimulation: slow oscillation disruption
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with insomnia<br>Patients with insomnia disorder according to DSM-5 criteria | Device: Auditory closed-loop stimulation: slow oscillation boosting<br>* Auditory-closed loop stimulation: slow oscillation boosting<br>Device: Auditory closed-loop stimulation: slow oscillation disruption<br>* Auditory closed-loop stimulation: slow oscillation disruption<br>Device: Sham stimulation<br>* Sham stimulation<br>|
| Experimental: Healthy controls<br>Healthy controls | Device: Auditory closed-loop stimulation: slow oscillation boosting<br>* Auditory-closed loop stimulation: slow oscillation boosting<br>Device: Auditory closed-loop stimulation: slow oscillation disruption<br>* Auditory closed-loop stimulation: slow oscillation disruption<br>Device: Sham stimulation<br>* Sham stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modulation Index | Measure of phase-amplitude coupling | Averaged across NREM sleep of the baseline night (about 6 hours) |