DepressionSMARTNCT05685771
Sleep Modulation as Antidepressant Randomized Trial
A study testing Phase-targeted auditory stimulation in people with Depression and Healthy, run by Giulia Da Poian at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to learn about the effects of phase-targeted auditory stimulation in depressed patients and healthy controls. The main questions it aims to answer are: Is auditory down-phase stimulation efficient in improving depression symptoms as compared to sham stimulation? Can mood and other… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Healthy
- What is being tested?
- Phase-targeted auditory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2023to 25 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female adults aged 18-55 years
- Motivated, no aversion against technology
- Able to give informed consent as documented by signature, and to follow the technical instructions
- Able to understand and speak German or English as required for the interview (HDRS) and to answer the questionnaires
- Diagnosis of depression according to DSM-5 criteria (depressed) OR no diagnosis of depression AND no depressive episode in the history (healthy)
- ≥17 points in Hamilton Depression Rating Score (HDRS, corresponding to at least moderate-mild depression, depressed) OR <8 points in HDRS (healthy)
- Stable or no pharmacological antidepressant therapy, no acute suicidal tendency (depressed)
Who cannot join
- Pregnant or lactating women, women planning to get pregnant during the study period
- Bipolar disorder or psychotic symptoms in the history
- Relevant disease or medication that could present a risk for the participant or that could influence study findings
- Known sleep apnea (diagnosed or ESS ≥10 points) or periodic limb movement syndrome
- Known alcoholism or drug abuse
- Diagnosed hearing impairment/presbycusis
Show all 16Show fewer
- Irregular intake of centrally depressing or stimulating medication known to alter sleep EEG (e.g., benzodiazepines)
- History of traumatic brain injury (except for concussion) or neurosurgical procedures/operations
- Known epilepsy or for any reason, intracranial space-occupying lesions or (infectious or autoimmune) inflammatory diseases of the central nervous system
- Shift workers
- Inability to follow the procedures of the study, e.g., due to language problems, dementia, etc.
- Skin diseases/skin problems (in the face/ear/chest area) or allergies that could be aggravated by electrode application
- Conditions that may interfere with the MRI (e.g., MR unsafe cardiac pacemaker or a defibrillator, MR unsafe metal in or near the head, spinal cord, eyes, or in the chest)
- Indications of sleep apnea (Apnea Hypopnea Index >15/h) or periodic limb movement syndrome (PLMS index >15/h) in the screening night
- Low stimulation efficiency (<500 stimulations detected by the device) in the screening night or in 3 subsequent home recording nights, e.g., due to very little deep sleep
- Participation in another clinical trial during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Symptomatic Benefit of Slow-wave Activity Reduction Using Wearables and Sensor-based Characterization of Depression: a Randomized, Counter-balanced Crossover Study
The goal of this clinical trial is to learn about the effects of phase-targeted auditory stimulation in depressed patients and healthy controls.
The main questions it aims to answer are:
- Is auditory down-phase stimulation efficient in improving depression symptoms as compared to sham stimulation?
- Can mood and other outcomes be prospectively estimated by multi-parametric passive data?
Participants will perform auditory stimulation using a wearable device at home and provide data on their phone usage and activity.
Researchers will compare depressed patients and healthy participants to see if auditory down-phase stimulation effects them differently.
Read the detailed description
This study consists of two parts:
CLINICAL TRIAL PART: This part will be conducted in depressed and age- and sex-matched healthy participants. It has a double-blind, randomized crossover design. Each participant will undergo 1 week of baseline monitoring, followed by 1 week of in-home stimulation and 1 week of placebo condition interleaved with 1 week wash-out period. The last night of each intervention week will take place in a laboratory setting. A final week of follow-up will follow the second intervention week.
The following data is collected:
- Single-channel EEG (at home) and high-density electroencephalogram (hdEEG) (in laboratory)
- MR imaging
- Daily questionnaires
- Passive behavioural and physiological measurements
MONITORING PART: This observational study part will be conducted in depressed participants only. Each participant will undergo 5 weeks of remote monitoring using wearable devices and smartphones. Patients not eligible for the CLINICAL TRIAL PART, or that meet an exclusion criterion at any point in the study, can be assigned to this study part.
- Conditions
- Depression, Healthy
- Being tested
- Phase-targeted auditory stimulation
- Keywords
- Healthy, Depression, Auditory stimulation, Sleep
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase-targeted auditory stimulationDevice
Bursts of pink noise (50 ms) played during deep non-REM sleep at specific phases of sleep slow waves.
| Study group | Role | What they receive |
|---|---|---|
| Auditory stimulation first | Other | This study group receives auditory stimulation in the first intervention week (second week of trial) and sham stimulation in the second intervention week (fourth week of trial). Receives: Device: Phase-targeted auditory stimulation |
| Sham stimulation first | Other | This study group receives sham stimulation in the first intervention week (second week of trial) and auditory stimulation in the second intervention week (fourth week of trial). Receives: Device: Phase-targeted auditory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity
Change in Hamilton Depression Rating Score (HDRS) as compared to baseline score. The 17-item HDRS is on a scale of 0-52 with higher scores indicating more severe symptomatology.
Measured: baseline; after first intervention week; after second intervention week
Secondary outcomes (5)
Response rate
Change in response rate in the Hamilton Depression Rating Score. Response is defined as a reduction of at least 50% compared to baseline or score <8 points.
Measured: after first intervention week; after second intervention week
Subjective momentary sleepiness
Compare momentary sleepiness using the Karolinska Sleepiness Scale (KSS) between the two intervention weeks. KSS scores range from 1-10 with higher scores indicating higher sleepiness.
Measured: first intervention week; second intervention week
Electroencephalographic (EEG) topography
Change in topography of the electric brain activity (EEG) during sham and stimulation night in the laboratory. Spectral decomposition of the signal will be performed to compare single frequency bins and established frequency bands (delta, theta, alpha, sigma, beta, gamma).
Measured: last night of first intervention week; last night of second intervention week
MR Spectroscopy
Changes in Glutamate/Glutamine (combined as Glx) in the dorsolateral prefrontal cortex as assessed by magnetic resonance spectroscopy between sham and stimulation weeks.
Measured: after first intervention week; after second intervention week
Brain connectivity
Change in resting state functional connectivity (fMRI) between sham and stimulation weeks.
Measured: after first intervention week; after second intervention week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Apr 2023
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giulia Da Poian
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich, University of Zurich, Psychiatric University Hospital, Zurich
- Responsible party
- Sponsor-investigator, Giulia Da Poian, ETH Zurich
- Investigators
- Giulia Da Poian, PhD, Principal investigator, Sensory-Motor Systems Lab, IRIS, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685771
- Sponsor's protocol ID
- 2022-D0092
- Acronym
- SMART
- Status last verified
- Jul 2024
- First submitted
- 3 Jan 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in sleep research and depression. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Symptomatic Benefit of Slow-wave Activity Reduction Using Wearables and Sensor-based Characterization of Depression: a Randomized, Counter-balanced Crossover Study
- ClinicalTrials.gov ID
- NCT05685771
- Acronym / sponsor ID
- SMART / 2022-D0092
- Conditions
- Depression, Healthy
- Keywords
- Healthy, Depression, Auditory stimulation, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Giulia Da PoianUniversity, hospital or other
- Collaborators
- ETH Zurich, University of Zurich, Psychiatric University Hospital, Zurich
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 17 Jan 2023 (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.
The goal of this clinical trial is to learn about the effects of phase-targeted auditory stimulation in depressed patients and healthy controls.
The main questions it aims to answer are:
- Is auditory down-phase stimulation efficient in improving depression symptoms as compared to sham stimulation?
- Can mood and other outcomes be prospectively estimated by multi-parametric passive data?
Participants will perform auditory stimulation using a wearable device at home and provide data on their phone usage and activity.
Researchers will compare depressed patients and healthy participants to see if auditory down-phase stimulation effects them differently.
Detailed description
This study consists of two parts:
CLINICAL TRIAL PART: This part will be conducted in depressed and age- and sex-matched healthy participants. It has a double-blind, randomized crossover design. Each participant will undergo 1 week of baseline monitoring, followed by 1 week of in-home stimulation and 1 week of placebo condition interleaved with 1 week wash-out period. The last night of each intervention week will take place in a laboratory setting. A final week of follow-up will follow the second intervention week.
The following data is collected:
- Single-channel EEG (at home) and high-density electroencephalogram (hdEEG) (in laboratory)
- MR imaging
- Daily questionnaires
- Passive behavioural and physiological measurements
MONITORING PART: This observational study part will be conducted in depressed participants only. Each participant will undergo 5 weeks of remote monitoring using wearable devices and smartphones. Patients not eligible for the CLINICAL TRIAL PART, or that meet an exclusion criterion at any point in the study, can be assigned to this study part.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory stimulation first | Other | Device: Phase-targeted auditory stimulationThis study group receives auditory stimulation in the first intervention week (second week of trial) and sham stimulation in the second intervention week (fourth week of trial). |
| Sham stimulation first | Other | Device: Phase-targeted auditory stimulationThis study group receives sham stimulation in the first intervention week (second week of trial) and auditory stimulation in the second intervention week (fourth week of trial). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female adults aged 18-55 years
- Motivated, no aversion against technology
- Able to give informed consent as documented by signature, and to follow the technical instructions
- Able to understand and speak German or English as required for the interview (HDRS) and to answer the questionnaires
- Diagnosis of depression according to DSM-5 criteria (depressed) OR no diagnosis of depression AND no depressive episode in the history (healthy)
Key exclusion criteria (16 listed)
- Pregnant or lactating women, women planning to get pregnant during the study period
- Bipolar disorder or psychotic symptoms in the history
- Relevant disease or medication that could present a risk for the participant or that could influence study findings
- Known sleep apnea (diagnosed or ESS ≥10 points) or periodic limb movement syndrome
- Known alcoholism or drug abuse
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 |
|---|---|---|
| Phase-targeted auditory stimulationBursts of pink noise (50 ms) played during deep non-REM sleep at specific phases of sleep slow waves. | Device | Auditory stimulation first, Sham stimulation first |
Primary outcome
Depression severity
Time frame: baseline; after first intervention week; after second intervention week
Change in Hamilton Depression Rating Score (HDRS) as compared to baseline score. The 17-item HDRS is on a scale of 0-52 with higher scores indicating more severe symptomatology.
5 secondary outcomes
Response rate
Time frame: after first intervention week; after second intervention week
Subjective momentary sleepiness
Time frame: first intervention week; second intervention week
Electroencephalographic (EEG) topography
Time frame: last night of first intervention week; last night of second intervention week
MR Spectroscopy
Time frame: after first intervention week; after second intervention week
Brain connectivity
Time frame: after first intervention week; after second intervention week
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 26 Jul 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in sleep research and depression. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Giulia Da Poian, PhD principal investigator
Sensory-Motor Systems Lab, IRIS, ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase-targeted auditory stimulation in people with Depression and Healthy, run by Giulia Da Poian 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 7 inclusion and 16 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 26 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?
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?
Depression severity (time frame: baseline; after first intervention week; after second intervention week). 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 26 Jul 2024.