Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Light at Night Study (LAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251234
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Helen Burgess, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Light Sensitivity Other: Light intensity, ~30 lux Other: Baseline light intensity, <1 lux Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: There is no masking. The dim light (<1 lux) condition is first, followed by the room light (~30 lux) condition. Participants are aware of this condition order.
Primary Purpose: Other
Official Title: Light at Night Study
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251234


Contacts
Layout table for location contacts
Contact: Parisa Vidafar, PhD 734-232-3389 pvidafar@umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Parisa Vidafar    734-512-6316    pvidafar@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Helen Burgess, PhD University of Michigan
Layout table for additonal information
Responsible Party: Helen Burgess, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT04251234    
Other Study ID Numbers: HUM00173528
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helen Burgess, University of Michigan:
Circadian
Light Intensity
Additional relevant MeSH terms:
Layout table for MeSH terms
Photophobia
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases