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NCT04845347 · ClinicalTrials.gov registry record · NA

A Wearable Morning Light Treatment for Postpartum Depression

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
95
Enrollment target

NCT04845347: Completed NA study, sponsored by University of Michigan.

NCT04845347 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 95 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04845347, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
95 participants
Enrollment target

Study Summary

This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock). Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re-Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results. The hypotheses regarding the bright light versus the placebo dim light of the study are: * morning bright light therapy will produce greater improvement from pre- to post-treatment on the Hamilton Rating Scale for Depression * morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms. * morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.

Primary Outcome

Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale (HAM-D) (17 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 - 52, where 0 means no depression, and 52 is the greatest possible depression. Generally, scores of 8 or higher represent clinical depression.

Interventions

  • DEVICE Bright Light Therapy
  • DEVICE Dim Light Therapy

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2021-06-23
Est. Completion 2025-07-24
Phase NA
University of Michigan

1,327 total trials

What the finished NCT04845347 record still lists

NCT04845347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which Bright Light Therapy is the first listed.

NCT04845347 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04845347 about?

NCT04845347 is a clinical study titled "A Wearable Morning Light Treatment for Postpartum Depression". This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock). Eligible participants will be enrolled and randomized after baseline assessments. In addition to...

What is the current status of trial NCT04845347?

This trial is currently completed. It is a NA study. The enrollment target is 95 participants. The study started on 2021-06-23. Estimated completion is 2025-07-24.

What interventions are being tested in trial NCT04845347?

The interventions under investigation include: Bright Light Therapy (DEVICE), Dim Light Therapy (DEVICE).

Who is sponsoring clinical trial NCT04845347?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04845347's enrollment target sits among peer trials

95 931st of 2000 higher than 1,066 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT04845347, the US trial registry maintained by the National Library of Medicine. NCT04845347 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.