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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04276064

Enrollment

Registered

2020-02-19

Start date

2021-11-01

Completion date

2024-02-14

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Sleep

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).

Interventions

DEVICEAuditory closed-loop stimulation: slow oscillation boosting

Auditory-closed loop stimulation: slow oscillation boosting

DEVICEAuditory closed-loop stimulation: slow oscillation disruption

Auditory closed-loop stimulation: slow oscillation disruption

DEVICESham stimulation

Sham stimulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026