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

March 1, 2024 updated by: Christoph Nissen
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christoph Nissen

Investigators

  • Principal Investigator: Christoph Nissen, MD, University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

February 14, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-02426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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