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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-02-14

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).

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Detailed Description

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Conditions

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Sleep Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Patients with insomnia

Patients with insomnia disorder according to DSM-5 criteria

Group Type EXPERIMENTAL

Auditory closed-loop stimulation: slow oscillation boosting

Intervention Type DEVICE

Auditory-closed loop stimulation: slow oscillation boosting

Auditory closed-loop stimulation: slow oscillation disruption

Intervention Type DEVICE

Auditory closed-loop stimulation: slow oscillation disruption

Sham stimulation

Intervention Type DEVICE

Sham stimulation

Healthy controls

Group Type EXPERIMENTAL

Auditory closed-loop stimulation: slow oscillation boosting

Intervention Type DEVICE

Auditory-closed loop stimulation: slow oscillation boosting

Auditory closed-loop stimulation: slow oscillation disruption

Intervention Type DEVICE

Auditory closed-loop stimulation: slow oscillation disruption

Sham stimulation

Intervention Type DEVICE

Sham stimulation

Interventions

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Auditory closed-loop stimulation: slow oscillation boosting

Auditory-closed loop stimulation: slow oscillation boosting

Intervention Type DEVICE

Auditory closed-loop stimulation: slow oscillation disruption

Intervention Type DEVICE

Sham stimulation

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes