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Light at Night Study (LAN)

Primary Purpose

Bipolar Disorder, Light Sensitivity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light intensity, ~30 lux
Baseline light intensity, <1 lux
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bipolar Disorder focused on measuring Circadian, Light Intensity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy controls

Bipolar I disorder

Arm Description

No co-morbid medical or psychiatry diagnoses No family history of mental illness No current medication use Non-smoking

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

Outcomes

Primary Outcome Measures

Melatonin levels
Melatonin will be reported as an average percentage of suppression in the ~30 lux condition as compared to <1 lux

Secondary Outcome Measures

Full Information

First Posted
January 30, 2020
Last Updated
August 4, 2021
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04251234
Brief Title
Light at Night Study
Acronym
LAN
Official Title
Light at Night Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID shutdown
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
August 4, 2021 (Actual)
Study Completion Date
August 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Light Sensitivity
Keywords
Circadian, Light Intensity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
No co-morbid medical or psychiatry diagnoses No family history of mental illness No current medication use Non-smoking
Arm Title
Bipolar I disorder
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Light intensity, ~30 lux
Intervention Description
~30 lux compared to very dim light baseline condition <1 lux
Intervention Type
Other
Intervention Name(s)
Baseline light intensity, <1 lux
Intervention Description
Very dim light condition
Primary Outcome Measure Information:
Title
Melatonin levels
Description
Melatonin will be reported as an average percentage of suppression in the ~30 lux condition as compared to <1 lux
Time Frame
Up to approximately 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Burgess, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Light at Night Study

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