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NCT07258485 · ClinicalTrials.gov registry record

A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)

A clinical trial of Depressive Disorder, Major, sponsored by Janssen Research & Development.

Recruiting
Registry status
80
Enrollment target
14
Study locations

NCT07258485: Recruiting study of Depressive Disorder, Major, sponsored by Janssen Research & Development.

NCT07258485 is a study of Depressive Disorder, Major that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 80 participants, below the 241-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (67% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07258485, a study of Depressive Disorder, Major, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
80 participants
Enrollment target
14
Study locations

Study 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.

Primary Outcome

Objective sleep EEG features in MDD participants will be assessed using dreem 3S headband. It will be used in this study to capture macro and micro sleep architecture including sleep initiation (latent to persistent sleep, sleep onset latency), sleep maintenance (rapid eye movement \[REM\] latency, total sleep time, REM percentage, and duration) and arousal features (stage shift index, number of awakenings). It also uses a 3D accelerometer to measure movements, head position, and respiratory rat

Conditions Studied

Study Locations (14)

California

  • Behavioral Research Specialists LLC - Glendale
  • Pacific Clinical Research Medical Group - Upland
  • Sunwise Clinical Research - Walnut Creek

Florida

  • Velocity Clinical Research - Hallandale
  • Meridian International Research - Miami Gardens

Massachusetts

  • Adams Clinical - Boston
  • Adams Clinical - Watertown

New York

  • Adams Clinical - New York
  • Adams Clinical - The Bronx

Illinois

  • IMA Clinical Research PC - Chicago

Pennsylvania

  • Adams Clinical - Philadelphia

Texas

  • Adams Clinical - DeSoto

Utah

  • Inner Space Research LLC - Orem

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2025-11-24
Est. Completion 2026-04-24
Janssen Research & Development

593 total trials

What NCT07258485 shows while recruiting

NCT07258485 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 241-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (67% lower).

The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 0 interventions.

NCT07258485 lists 14 locations in 9 states (California, Florida, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT07258485 about?

NCT07258485 is a clinical study titled "A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)". 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). ...

What is the current status of trial NCT07258485?

This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2025-11-24. Estimated completion is 2026-04-24.

What conditions does trial NCT07258485 study?

This clinical trial studies the following conditions: Depressive Disorder, Major.

Who is sponsoring clinical trial NCT07258485?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07258485 being conducted?

This trial has 14 study locations across California, Florida, Illinois, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depressive Disorder, Major

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07258485's enrollment target sits among peer trials

80 31st of 52 higher than 21 of 52 other Depressive Disorder, Major trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depressive Disorder, Major trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07258485, the US trial registry maintained by the National Library of Medicine. NCT07258485 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.