Light at Night Study (LAN)

August 4, 2021 updated by: Helen Burgess, University of Michigan
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy controls
  • No co-morbid medical or psychiatry diagnoses
  • No family history of mental illness
  • No current medication use
  • Non-smoking
Other: Light intensity, ~30 lux
~30 lux compared to very dim light baseline condition <1 lux
Other: Baseline light intensity, <1 lux
Very dim light condition
EXPERIMENTAL: Bipolar I disorder
  • Clinical diagnosis of Bipolar I disorder
  • Can be (not required, not exclusionary) taking lithium and/or sodium valproate and/or antidepressants
  • Can be (not required, not exclusionary) light smokers
Other: Light intensity, ~30 lux
~30 lux compared to very dim light baseline condition <1 lux
Other: Baseline light intensity, <1 lux
Very dim light condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melatonin levels
Time Frame: Up to approximately 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Helen Burgess, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2020

Primary Completion (ACTUAL)

August 4, 2021

Study Completion (ACTUAL)

August 4, 2021

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (ACTUAL)

January 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00173528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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