DepressionNCT03133013
Objective Evaluation of Depression Using Sleep EEG
A study testing SLEEPSCOPE in people with Depression, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to test the ability of a brainwave measurement device (SLEEPSCOPE) in identifying and assisting in the diagnosis of depression. The brainwave data from individuals with untreated depression and healthy participants will be collected and analyzed. Read more about this study
- Who is it for?
- Ages 30 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- SLEEPSCOPE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 31 May 2019
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals with Untreated Depression:
- 16 men and 16 women aged from 30 to 59 years, with an approximate ethnic balance of 10 Asian, 3 White and 3 other ethnicity for each gender, whom are diagnosed with Major Depressive Disorder by a psychiatric specialist of this research according to MINI screening and DSM-5 criteria, and defined as a score of 15 or higher on the clinician-administered Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9).
- Healthy Participants:
- 16 men and 16 women age-, ethnic-, and gender-matched healthy participants to the cohort with untreated depression, with absence of mental disorders, including but not limited to depression and sleep disorders, by a psychiatric specialist according to MINI screening and DSM-5 criteria, and negative Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9).
Who cannot join
- Participants corresponding to any of the following conditions are considered ineligible for the trial.
- Diagnosed with epilepsy or other organic brain disorder.
- Medical conditions resulting in depressive symptoms such as hypothyroidism, Cushing's disease, systemic lupus erythematosus; neurological conditions resulting in depressive symptoms such as Parkinson's disease, Huntington's disease, multiple sclerosis
- Patients with suspected sleep apnea, based on symptoms and a BMI of 30 or greater
- Prescribed interferon regularly with stimulants, opioid drugs (Ritalin, Opioid, etc.) and steroids
- Repetitive thoughts of death, current thoughts about suicide, suicide attempts, or a suicide plan
Show all 11Show fewer
- Tested positive to controlled substance use by a urine drug screening before commencement of testing
- Current or past drug or alcohol dependence
- Shift work or rotating work schedule
- Nursing, pregnant or planning to become pregnant
- Participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Sleep Medicine Center
Redwood City, California, 94063
About this study
Official title: A Study on Realization of Objective Evaluation Method of Depression Using Sleep EEG
The purpose of this study is to test the ability of a brainwave measurement device (SLEEPSCOPE) in identifying and assisting in the diagnosis of depression. The brainwave data from individuals with untreated depression and healthy participants will be collected and analyzed. The ability to obtain brainwave data from individuals in their homes while they're sleeping would represent a significant advance in depression research.
Read the detailed description
The purpose of study is to collect and analyze human sleeping brainwave data, to better understand depression in humans.
First visit:
- Informed consent procedures, including explanation of research background, purpose, details of implementation, and study benefits and risks
- Interview with questionnaires (MINI International Psychiatric Interview, Hamilton Rating Scale for Depression, Beck Depression Inventory, Patient Health Questionnaire for Depression [PHQ-9]), physical examination.
- Urine drug sample for screening of controlled substances.
- Inform participants that those qualifying will be informed whether or not to proceed with second visit
Second visit:
- Explanation of EEG measurement (placement of two electrodes, one on the forehead and one behind the ear)
- Sleep diary provided for participant to complete at home for each night until third visit
- Distribution of EEG devices for home use
- EEG measurement conducted at participant's residence for three nights of stable sleep-wake cycles
Third visit:
- Collect EEG devices and check completeness of downloaded data
- Conditions
- Depression
- Being tested
- SLEEPSCOPE
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLEEPSCOPEDevice
Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Untreated Depression | Experimental | 32 participants diagnosed with Major Depressive Disorder by a psychiatric specialist of this research according to MINI screening and Diagnostic and Statistical Manual (DSM-5) criteria, and defined as a score of 15 or higher on the clinician-administered Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9). The participants will be attached to the SLEEPSCOPE device. Receives: Device: SLEEPSCOPE |
| Healthy Participants | Other | 32 healthy participants with absence of mental disorders, including but not limited to depression and sleep disorders, by a psychiatric specialist according to MINI screening and Diagnostic and Statistical Manual (DSM-5) criteria, and negative Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9). The participants will be attached to the SLEEPSCOPE device. Receives: Device: SLEEPSCOPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assist in the diagnosis of depression
The SLEEPSCOPE data will be analyzed to determine if it can help to identify individuals with depression
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 May 2017
- Primary completion31 May 2019
- Study completion31 May 2019
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clete A. Kushida, Stanford University
- Investigators
- Clete A Kushida, M.D., Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133013
- Sponsor's protocol ID
- 41103
- Status last verified
- Dec 2019
- First submitted
- 25 Apr 2017
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Realization of Objective Evaluation Method of Depression Using Sleep EEG
- ClinicalTrials.gov ID
- NCT03133013
- Acronym / sponsor ID
- 41103
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 28 Apr 2017 (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 purpose of this study is to test the ability of a brainwave measurement device (SLEEPSCOPE) in identifying and assisting in the diagnosis of depression. The brainwave data from individuals with untreated depression and healthy participants will be collected and analyzed. The ability to obtain brainwave data from individuals in their homes while they're sleeping would represent a significant advance in depression research.
Detailed description
The purpose of study is to collect and analyze human sleeping brainwave data, to better understand depression in humans.
First visit:
- Informed consent procedures, including explanation of research background, purpose, details of implementation, and study benefits and risks
- Interview with questionnaires (MINI International Psychiatric Interview, Hamilton Rating Scale for Depression, Beck Depression Inventory, Patient Health Questionnaire for Depression [PHQ-9]), physical examination.
- Urine drug sample for screening of controlled substances.
- Inform participants that those qualifying will be informed whether or not to proceed with second visit
Second visit:
- Explanation of EEG measurement (placement of two electrodes, one on the forehead and one behind the ear)
- Sleep diary provided for participant to complete at home for each night until third visit
- Distribution of EEG devices for home use
- EEG measurement conducted at participant's residence for three nights of stable sleep-wake cycles
Third visit:
- Collect EEG devices and check completeness of downloaded data
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with Untreated Depression | Experimental | Device: SLEEPSCOPE32 participants diagnosed with Major Depressive Disorder by a psychiatric specialist of this research according to MINI screening and Diagnostic and Statistical Manual (DSM-5) criteria, and defined as a score of 15 or higher on the clinician-administered Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9). The participants will be attached to the SLEEPSCOPE device. |
| Healthy Participants | Other | Device: SLEEPSCOPE32 healthy participants with absence of mental disorders, including but not limited to depression and sleep disorders, by a psychiatric specialist according to MINI screening and Diagnostic and Statistical Manual (DSM-5) criteria, and negative Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9). The participants will be attached to the SLEEPSCOPE device. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 16 men and 16 women aged from 30 to 59 years, with an approximate ethnic balance of 10 Asian, 3 White and 3 other ethnicity for each gender, whom are diagnosed with Major Depressive Disorder by a psychiatric specialist of this research according to MINI screening and DSM-5 criteria, and defined as a score of 15 or higher on the clinician-administered Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9).
- 16 men and 16 women age-, ethnic-, and gender-matched healthy participants to the cohort with untreated depression, with absence of mental disorders, including but not limited to depression and sleep disorders, by a psychiatric specialist according to MINI screening and DSM-5 criteria, and negative Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9).
Key exclusion criteria (11 listed)
- Participants corresponding to any of the following conditions are considered ineligible for the trial.
- Diagnosed with epilepsy or other organic brain disorder.
- Medical conditions resulting in depressive symptoms such as hypothyroidism, Cushing's disease, systemic lupus erythematosus; neurological conditions resulting in depressive symptoms such as Parkinson's disease, Huntington's disease, multiple sclerosis
- Patients with suspected sleep apnea, based on symptoms and a BMI of 30 or greater
- Prescribed interferon regularly with stimulants, opioid drugs (Ritalin, Opioid, etc.) and steroids
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 |
|---|---|---|
| SLEEPSCOPEBrainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear | Device | Healthy Participants, Individuals with Untreated Depression |
Primary outcome
Assist in the diagnosis of depression
Time frame: 1 month
The SLEEPSCOPE data will be analyzed to determine if it can help to identify individuals with depression
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 12 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Clete A Kushida, M.D., Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLEEPSCOPE in people with Depression, run by Stanford University at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 12 Dec 2019. 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 United States. 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?
Assist in the diagnosis of depression (time frame: 1 month). 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 12 Dec 2019.