SleepNCT04276064
Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity
A study testing Auditory closed-loop stimulation: slow oscillation boosting and Auditory closed-loop stimulation: slow oscillation disruption in people with Sleep and Insomnia, run by Christoph Nissen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Auditory closed-loop stimulation: slow oscillation boosting and Auditory closed-loop stimulation: slow oscillation disruption
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2021to 14 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients: diagnosis of ID according to DSM 5 criteria; for controls: mentally and somatically healthy
- Age 18 to 65 years
- Written informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Auditory closed-loop stimulation: slow oscillation boosting, Auditory closed-loop stimulation: slow oscillation disruption, Sham stimulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory closed-loop stimulation: slow oscillation boostingDevice
Auditory-closed loop stimulation: slow oscillation boosting
Auditory closed-loop stimulation: slow oscillation disruptionDevice
Auditory closed-loop stimulation: slow oscillation disruption
Sham stimulationDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Patients with insomnia | Experimental | Patients with insomnia disorder according to DSM-5 criteria Receives: Device: Auditory closed-loop stimulation: slow oscillation boosting; Device: Auditory closed-loop stimulation: slow oscillation disruption; Device: Sham stimulation |
| Healthy controls | Experimental | Healthy controls Receives: Device: Auditory closed-loop stimulation: slow oscillation boosting; Device: Auditory closed-loop stimulation: slow oscillation disruption; Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation Index
Measure of phase-amplitude coupling
Measured: Averaged across NREM sleep of the baseline night (about 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Nov 2021
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Nissen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Nissen, University of Bern
- Investigators
- Christoph Nissen, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276064
- Sponsor's protocol ID
- 2019-02426
- Other IDs
- 2019
- Status last verified
- Mar 2024
- First submitted
- 17 Feb 2020
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30848042
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity
- ClinicalTrials.gov ID
- NCT04276064
- Acronym / sponsor ID
- 2019-02426
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Christoph NissenUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with insomnia | Experimental | Device: Auditory closed-loop stimulation: slow oscillation boosting, Device: Auditory closed-loop stimulation: slow oscillation disruption, Device: Sham stimulationPatients with insomnia disorder according to DSM-5 criteria |
| Healthy controls | Experimental | Device: Auditory closed-loop stimulation: slow oscillation boosting, Device: Auditory closed-loop stimulation: slow oscillation disruption, Device: Sham stimulationHealthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For patients: diagnosis of ID according to DSM 5 criteria; for controls: mentally and somatically healthy
- Age 18 to 65 years
- Written informed consent
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory closed-loop stimulation: slow oscillation boostingAuditory-closed loop stimulation: slow oscillation boosting | Device | Healthy controls, Patients with insomnia |
| Auditory closed-loop stimulation: slow oscillation disruptionAuditory closed-loop stimulation: slow oscillation disruption | Device | Healthy controls, Patients with insomnia |
| Sham stimulationSham stimulation | Device | Healthy controls, Patients with insomnia |
Primary outcome
Modulation Index
Time frame: Averaged across NREM sleep of the baseline night (about 6 hours)
Measure of phase-amplitude coupling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 30848042Mikutta 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Nissen, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory closed-loop stimulation: slow oscillation boosting and Auditory closed-loop stimulation: slow oscillation disruption in people with Sleep and Insomnia, run by Christoph Nissen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modulation Index (time frame: Averaged across NREM sleep of the baseline night (about 6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04276064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.