An interventional study of Light therapy A via the Re-Timer® and Light therapy B via the Re-Timer® in Stress, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.
Brain emotional processing was determined with the Emotional Faces Assessment Task (EFAT). In this task, participants view a trio of faces and match one of the two faces (bottom) that expresses the same emotion as the target face (top). The faces display one of five expressions (angry, happy, fearful, sad, neutral) and the other (incongruent) probe face always displays a neutral (or happy if the target is neutral) expression. The paradigm consists of 20 face trials per expression and 20 shape trials, presented in pseudorandomized order, separated by a 3-7 sec intertrial blank screen with fixation cross.
University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
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Exclusion Criteria:
-15 minutes/day
Device: Light therapy A via the Re-Timer®
-30 minutes/day
Device: Light therapy B via the Re-Timer®
-60 minutes/day
Device: Light therapy C via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
Also known as: Re-Timer®
Subjects will conduct light treatment in the mornings at home.
Also known as: Re-Timer®
Subjects will conduct light treatment in the mornings at home.
Also known as: Re-Timer®
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
Participants completed the Emotional Faces Assessment Task (EFAT) during the fMRI scan. The average blood-oxygen-level-dependent (BOLD) signal change between the display of negative faces versus display of shapes was derived for the left and right amygdala separately. Higher levels indicate greater amygdala reactivity to negative faces versus display of shapes.
Time frame: Baseline and treatment week 2 and treatment week 4
| Milestone | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® |
|---|---|---|---|
| Started | 15 | 15 | 16 |
| Completed | 14 | 13 | 15 |
| Not completed | 1 | 2 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: No time for study | 0 | 2 | 0 |
| Withdrew: Family emergency | 1 | 0 | 0 |
Participants completed the Emotional Faces Assessment Task (EFAT) during the fMRI scan. The average blood-oxygen-level-dependent (BOLD) signal change between the display of negative faces versus display of shapes was derived for the left and right amygdala separately. Higher levels indicate greater amygdala reactivity to negative faces versus display of shapes.
| beta weights | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® |
|---|---|---|---|
| Baseline (left amygdala) | 0.1287 ± 0.0842 | 0.1532 ± 0.0828 | 0.2134 ± 0.1362 |
| After 2 weeks of light treatment (left amygdala) | 0.1048 ± 0.0770 | 0.1248 ± 0.0855 | 0.0806 ± 0.1582 |
| After 4 weeks of light treatment (left amygdala) | 0.1155 ± 0.0927 | 0.1191 ± 0.1047 | 0.1375 ± 0.1399 |
| Baseline (right amygdala) | 0.1437 ± 0.1480 | 0.1969 ± 0.0882 | 0.1899 ± 0.0830 |
| After 2 weeks of light treatment (right amygdala) | 0.1104 ± 0.0715 | 0.1176 ± 0.1042 | 0.1012 ± 0.0716 |
| After 4 weeks of light treatment (right amygdala) | 0.1087 ± 0.1159 | 0.1107 ± 0.1141 | 0.1303 ± 0.0905 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Light Therapy A Via the Re-Timer® | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Light Therapy B Via the Re-Timer® | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Light Therapy C Via the Re-Timer® | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Event | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® |
|---|---|---|---|
| Light-triggered headacheGeneral disorders | 0/15 | 0/15 | 1/16 |
| Age, Continuous(years) | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® | Total |
|---|---|---|---|---|
| Mean | 34.10 ± 12.03 | 36.45 ± 10.58 | 30.69 ± 8.85 | 33.68 ± 10.57 |
| Sex: Female, Male(Participants) | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® | Total |
|---|---|---|---|---|
| Female | 12 | 12 | 10 | 34 |
| Male | 3 | 3 | 6 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 1 | 4 |
| Not Hispanic or Latino | 14 | 13 | 15 | 42 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 | 2 |
| Asian | 0 | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 0 | 3 |
| White | 12 | 12 | 13 | 37 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® | Total |
|---|---|---|---|---|
| United States | 15 | 15 | 16 | 46 |
| fMRI BOLD signal change in amygdala(beta weight) | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® | Total |
|---|---|---|---|---|
| fMRI BOLD signal change in left amygdala | 0.1311 ± 0.0816 | 0.1410 ± 0.0822 | 0.2065 ± 0.1333 | 0.1589 ± 0.1047 |
| fMRI BOLD signal change in right amygdala | 0.1611 ± 0.1577 | 0.1800 ± 0.0936 | 0.1858 ± 0.0812 | 0.1753 ± 0.1147 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff. That includes that identified research information will be entered into the National Institute of Mental Health's Database for Clinical Trials related to Mental Illness (NDCT)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
Access criteria: Researchers requesting data will first have to sign a data sharing agreement, agreeing to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, electronically securing the data while in use, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, no use of the data for commercial purposes and proper acknowledgement of the data resource.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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