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

Not Applicable

Completed

• Conditions: Sleep; Insomnia
• Interventions: Device: Sham stimulation

• Registration Number: NCT04276064
• Lead Sponsor: Christoph Nissen

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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2021-11-01
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy controls	Sham stimulation	Healthy controls
Patients with insomnia	Sham stimulation	Patients with insomnia disorder according to DSM-5 criteria

Primary Outcome Measures

Name	Time	Method
Modulation Index	Averaged across NREM sleep of the baseline night (about 6 hours)	Measure of phase-amplitude coupling

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland