ClinicalTrials.gg
TerminatedNCT04251234LANUpdated Aug 12, 2021

Light at Night Study

An interventional study of Light intensity, ~30 lux and Baseline light intensity, <1 lux in Bipolar Disorder and Light Sensitivity, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-12.

Sponsored by University of Michigan · Not applicable, Interventional, and Other

Why this study was terminated
COVID shutdown
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bipolar Disorder
  • Light Sensitivity

Keywords

  • Circadian
  • Light Intensity
03

In context

Bipolar Disorder

1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.

This study's enrollment of 2 is below the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion Criteria:

  • Color blindness
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • 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 · Other: Baseline light intensity, <1 lux

  • 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 · Other: Baseline light intensity, <1 lux

Interventions

  • OtherLight intensity, ~30 lux

    \~30 lux compared to very dim light baseline condition \<1 lux

  • OtherBaseline light intensity, <1 lux

    Very dim light condition

06

What researchers measure

Primary outcomes

  1. Melatonin levels

    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

07

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48105, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04251234
Responsible party
Helen Burgess (Professor of Psychiatry, University of Michigan) — Principal investigator
First posted
Jan 31, 2020
Start date
Oct 15, 2020
Primary completion
Aug 4, 2021
Completion
Aug 4, 2021
Last update
Aug 12, 2021

Study contacts

Helen Burgess, PhD
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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