Spectral Lighting and Intestinal Failure
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Study ID
- NCT06094504
- Status
- Enrolling By Invitation
Conditions
- Intestinal Failure
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 1 Year
- Healthy Volunteers
- Not accepted
Interventions
- Spectral Lighting — OTHERSpectral room lighting containing violet and blue wavelengths of light capable of stimulating non-visual opsins including OPN5 and OPN3.
Study Details
The goal of this exploratory n-of-1-study is to compare markers of metabolism in infants with intestinal failure between two lighting environments. Investigators are seeking to learn whether supplementing the lighting environment of infants with intestinal failure with blue and violet wavelengths of light will allow more efficient utilization of the nutrition provided to participants by influencing hormones involved in regulation of growth and development as compared to a conventional lighting environment. Pre-clinical studies suggest that violet and blue wavelengths of light are involved in molecular pathways that help regulate metabolic activity.
Key Dates
- Start date
- Mar 1, 2024
- Status verified
- Dec 2024
- Primary completion
- Sep 15, 2026
- Completion
- Mar 15, 2027
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Lighting cycling (Spectral vs Conventional)The study protocol will commence the Monday after study subject enrollment, if medically feasible, and will consist of four weeks of alternating periods of 3 days of daytime conventional (CON) hospital lighting followed by 4 days of daytime full spectrum lighting (FS) including violet and blue light wavelengths.
Primary Outcome Measure
plasma protein concentration of insulin [ Time Frame: For four weeks, once a week for each lighting condition and once a week during the predawn hours after each lighting condition, for a total of four samples per week. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | - |
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