Major Depressive DisorderNCT06443216
Sleep Modulation to Treat Depression
A study testing Auditory closed-loop stimulation in people with Major Depressive Disorder and Healthy, run by Christoph Nissen at 1 site in Switzerland.
Trial summary
Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Healthy
- What is being tested?
- Auditory closed-loop stimulation
- 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
- 22 Jul 2024to Jul 2026
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- MDD according to ICD-10 criteria (F32.1/2, F33.1/2; i.e. unipolar depression) for patient group
Who cannot join
- Relevant psychiatric disorders (other than MDD for the patient group), such as organic psychiatric disorders, lifetime history of substance dependency or current substance abuse (smoking will be allowed for recruitment reasons), schizophrenia or other psychotic disorders, affective disorders including bipolar disorder, borderline personality disorder, autism or other severe psychiatric disorders
- Known pregnancy
- Unstable medical conditions, such as unstable cardiovascular or metabolic disorders, etc.
- Relevant neurological disorders, including epilepsy, stroke, etc.
- Organic sleep disorders including relevant sleep apnea (AHI>15/h), periodic limb movement disorder (PLMS index>5/h), Restless-Legs-Syndrome (RLS), narcolepsy, circadian rhythm disorder or shift work/ jet lag
- Intake of medication affecting the central nervous system (other than antidepressants and lithium in patients); patients receiving benzodiazepines or (es)ketamine will not be included
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- Current brain stimulation treatment, such as electroconvulsive therapy (ECT), TMS or deep brain stimulation
- Contraindications for tDCS or TMS studies, including but not limited to metal in the head/ brain or epilepsy
- Hearing impairment or tinnitus (auditory stimulation study)
- Inability to follow the procedures of the study (for example due to language problems)
- Left-handedness
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva
Geneva
Christoph Nissen, Prof. Dr. med.
About this study
Official title: Auditory Closed-loop Modulation of Slow Wave Sleep to Treat Major Depressive Disorder
Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.
Read the detailed description
The planned study is a single-centre, doubled-blind, randomized, sham controlled, repeated measures within-subject (stimulation and sham) study including patients with major depression and healthy controls, across four sleep laboratory nights (adaptation, baseline, stimulation and sham in counterbalanced order). The investigators will test the primary hypothesis that auditory-closed loop suppression of slow wave sleep will improve depressive clinical symptomatology compared to sham stimulation.
- Conditions
- Major Depressive Disorder, Healthy
- Being tested
- Auditory closed-loop stimulation, Sham stimulation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory closed-loop stimulationDevice
Auditory closed-loop suppression of slow wave sleep
Sham stimulationDevice
No auditory stimulation
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients with major depressive disorder according to ICD-10 criteria Receives: Device: Auditory closed-loop stimulation; Device: Sham stimulation |
| Healthy Group | Experimental | Healthy controls Receives: Device: Auditory closed-loop stimulation; Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Åsberg Depression Rating Scale
Measure of the severity of depressive symptomatology
The scores range between 0 to 60. The higher the score, the more symptamology of depression the subjects presents.
Measured: Up to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start22 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Christoph Nissen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Nissen, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443216
- Sponsor's protocol ID
- 2023-01804
- Other IDs
- 2023
- Status last verified
- Jul 2024
- First submitted
- 22 May 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Closed-loop Modulation of Slow Wave Sleep to Treat Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06443216
- Acronym / sponsor ID
- 2023-01804
- Conditions
- Major Depressive Disorder, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Christoph NissenUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Jun 2024 (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.
Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.
Detailed description
The planned study is a single-centre, doubled-blind, randomized, sham controlled, repeated measures within-subject (stimulation and sham) study including patients with major depression and healthy controls, across four sleep laboratory nights (adaptation, baseline, stimulation and sham in counterbalanced order). The investigators will test the primary hypothesis that auditory-closed loop suppression of slow wave sleep will improve depressive clinical symptomatology compared to sham stimulation.
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 |
|---|---|---|
| Experimental Group | Experimental | Device: Auditory closed-loop stimulation, Device: Sham stimulationPatients with major depressive disorder according to ICD-10 criteria |
| Healthy Group | Experimental | Device: Auditory closed-loop stimulation, Device: Sham stimulationHealthy controls |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Written informed consent
- MDD according to ICD-10 criteria (F32.1/2, F33.1/2; i.e. unipolar depression) for patient group
Key exclusion criteria (11 listed)
- Relevant psychiatric disorders (other than MDD for the patient group), such as organic psychiatric disorders, lifetime history of substance dependency or current substance abuse (smoking will be allowed for recruitment reasons), schizophrenia or other psychotic disorders, affective disorders including bipolar disorder, borderline personality disorder, autism or other severe psychiatric disorders
- Known pregnancy
- Unstable medical conditions, such as unstable cardiovascular or metabolic disorders, etc.
- Relevant neurological disorders, including epilepsy, stroke, etc.
- Organic sleep disorders including relevant sleep apnea (AHI>15/h), periodic limb movement disorder (PLMS index>5/h), Restless-Legs-Syndrome (RLS), narcolepsy, circadian rhythm disorder or shift work/ jet lag
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 stimulationAuditory closed-loop suppression of slow wave sleep | Device | Experimental Group, Healthy Group |
| Sham stimulationNo auditory stimulation | Device | Experimental Group, Healthy Group |
Primary outcome
Montgomery Åsberg Depression Rating Scale
Time frame: Up to three weeks
Measure of the severity of depressive symptomatology The scores range between 0 to 60. The higher the score, the more symptamology of depression the subjects presents.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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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.
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 in people with Major Depressive Disorder and Healthy, 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Nissen, Prof. Dr. med. (+41.22.305.45.38, christoph.nissen@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Åsberg Depression Rating Scale (time frame: Up to three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.