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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 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 95 participants.
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.
Interventions
- DEVICE Bright Light Therapy
- DEVICE Dim Light Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2021-06-23 |
| Est. Completion | 2025-07-24 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04845347
The ClinicalTrials.gov registry entry for NCT04845347 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bright Light Therapy is the first listed.
NCT04845347 reports 0 study locations.
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.
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