A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in … (NCT07258485) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)
United States94 participantsStarted 2025-11-24
Plain-language summary
The purpose of this study is to evaluate sleep in participants with Major Depressive Disorder with moderate to severe insomnia symptoms (MDDIS) or MDD with no or mild insomnia symptoms (non-MDDIS), using an at-home sleep Electroencephalogram (EEG; a device that records brain activity during sleep). The study also aims to examine the association between objective sleep EEG features (measured using devices) and subjective sleep measures (self-reported experiences, such as how a person feels about their sleep) in participants with MDDIS or non-MDDIS.
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Participants must be medically stable, based on investigator review of medical history, vital signs (including blood pressure), and clinical judgment. In cases of any medical concern, the investigator has the option to perform local 12-lead electrocardiogram (ECG) or local clinical laboratory testing at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
* Meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 axis I disorders-clinical trials version (SCID-CT). Must be diagnosed with first depressive episode prior to age 60
* Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration started in the current episode of depression. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression. An inadequate response is defined as less than (\<) 50 percent (%) reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms present, and overall good tolerability, as assessed by the massachusetts general hospital-antidepressant treatment response questionnaire (MGH-ATRQ). An adequate trial is defined as…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is no longer actively enrolling — is there any chance I could still be considered, or is enrollment completely closed?
2Since this trial is focused on measuring and characterizing sleep brain activity rather than testing a new treatment, what would I actually gain from participating — would I receive any feedback on my own sleep EEG results or just contribute data to research?
3The study uses a wearable EEG headband called the Dreem 3S that I'd presumably wear at home while sleeping — how disruptive or demanding is that, and do you think it's realistic for my situation?
4This trial separates MDD patients into those with moderate-to-severe insomnia and those without — given my specific symptoms, which group would I likely fall into, and does that affect anything about how I'd be involved?
5Since this is an observational study measuring sleep patterns rather than trialing a treatment, would you recommend I pursue this alongside standard depression treatment, or is there a more directly therapeutic option I should prioritize first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterization of Objective Sleep Electroencephalogram (EEG) Features in Major Depressive Disorder Participants with Moderate to Severe Insomnia Symptoms (MDDIS) or Non-MDDIS As Assessed by Dreem 3S Headband
Timeframe: Day -7 to Day -1
2
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by Consensus Sleep Diary (CSD)
Timeframe: Day -6 to Day 1
3
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by the Structured Interview Guide (SIGH-D) Used to Implement the 17 item Hamilton Depression Rating Scale (HRSD17)
Timeframe: Day -7 to Day -1
4
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD)- 8a Short Forms
Timeframe: Day -7 to Day -1
5
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by PROMIS-SD- 4a Short Forms
Timeframe: Day -7 to Day -1
6
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by PROMIS-SD- 10a Short Forms