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Objective Evaluation of Depression Using Sleep EEG

Primary Purpose

Depression

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SLEEPSCOPE

About this trial

This is an interventional diagnostic trial for Depression

Eligibility Criteria

30 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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
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

Sites / Locations

Stanford Sleep Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Individuals with Untreated Depression

Healthy Participants

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Assist in the diagnosis of depression

The SLEEPSCOPE data will be analyzed to determine if it can help to identify individuals with depression

Secondary Outcome Measures

Full Information

NCT ID

NCT03133013

First Posted

April 25, 2017

Last Updated

December 10, 2019

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03133013

Brief Title

Objective Evaluation of Depression Using Sleep EEG

Official Title

A Study on Realization of Objective Evaluation Method of Depression Using Sleep EEG

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

May 31, 2019 (Actual)

Study Completion Date

May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individuals with Untreated Depression

Arm Type

Experimental

Arm Description

Arm Title

Healthy Participants

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

SLEEPSCOPE

Intervention Description

Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear

Primary Outcome Measure Information:

Title

Assist in the diagnosis of depression

Description

The SLEEPSCOPE data will be analyzed to determine if it can help to identify individuals with depression

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clete A Kushida, M.D., Ph.D.

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Sleep Medicine Center

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Objective Evaluation of Depression Using Sleep EEG

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