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NCT04251234 Clinical Trial

Light at Night Study

Bipolar Disorder Clinical Trial

— LAN  

Official title:
Light at Night Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04251234
Other study ID # HUM00173528
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date August 4, 2021

Study information
Verified date August 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study.

Description:

The bipolar disorder I and healthy control arms are recruited from the existing Heinz C. Prechter Bipolar Research Program at the University of Michigan.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date August 4, 2021
Est. primary completion date August 4, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - BMI 18-30 kg/m2 - Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary - Healthy eyes as ascertained by eye exam at University of Michigan Kellogg Eye Center - Willing and able to maintain stable sleep schedule during study. - Participants will be breathalyzed and undergo urine drugs screens at every lab visit - Acknowledge and understand that participants cannot drive themselves home after certain lab visits. Note that the research team will provide a travel stipend of $10 per visit to offset potential rideshare/taxi costs Exclusion Criteria: - Color blindness

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Light intensity, ~30 lux
~30 lux compared to very dim light baseline condition <1 lux
• Baseline light intensity, <1 lux
Very dim light condition

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Melatonin levels Melatonin will be reported as an average percentage of suppression in the ~30 lux condition as compared to <1 lux Up to approximately 6 weeks
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