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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276064
• Other study ID #: 2019-02426
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: February 14, 2024

Study information

• Verified date: March 2024
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 14, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep

Intervention

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

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Christoph Nissen

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Mikutta C, Feige B, Maier JG, Hertenstein E, Holz J, Riemann D, Nissen C. Phase-amplitude coupling of sleep slow oscillatory and spindle activity correlates with overnight memory consolidation. J Sleep Res. 2019 Dec;28(6):e12835. doi: 10.1111/jsr.12835. Epub 2019 Mar 7. — View Citation

Outcome

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

External Links

•   Website research group