LAN: Light at Night Study

Sponsor

University of Michigan (Other)

Overall Status

Terminated

CT.gov ID

NCT04251234

Collaborator

(none)

Enrollment

Location

Arms

9.6

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder Light Sensitivity	Other: Light intensity, ~30 lux Other: Baseline light intensity, <1 lux	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2 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 :

Oct 15, 2020

Actual Primary Completion Date :

Aug 4, 2021

Actual Study Completion Date :

Aug 4, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Melatonin levels [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48105

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Helen Burgess, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Helen Burgess, Professor of Psychiatry, University of Michigan

ClinicalTrials.gov Identifier:

NCT04251234

Other Study ID Numbers:

HUM00173528

First Posted:

Jan 31, 2020

Last Update Posted:

Aug 12, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Helen Burgess, Professor of Psychiatry, University of Michigan

Circadian

Light Intensity

Additional relevant MeSH terms:

Photophobia

Bipolar Disorder

Study Results

No Results Posted as of Aug 12, 2021