Trials Sponsors Conditions Drugs Pricing

Conditions

Bipolar Disorder Light Sensitivity

Keywords

CircadianLight Intensity

Outcome Measures

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
Up to approximately 6 weeks

Study Arms (2)

Healthy controls

EXPERIMENTAL

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

Other: Light intensity, ~30 luxOther: Baseline light intensity, <1 lux

Bipolar I disorder

EXPERIMENTAL

* 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 luxOther: Baseline light intensity, <1 lux

Interventions

Light intensity, ~30 luxOther

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

Bipolar I disorderHealthy controls

Baseline light intensity, <1 luxOther

Very dim light condition

Bipolar I disorder

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

BMI 18-30 kg/m2
Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary

Sponsors & Collaborators

University of Michigan
Otherlead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

MeSH Terms

Conditions

Bipolar DisorderPhotophobia

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Helen Burgess, PhD
University of Michigan
PRINCIPAL INVESTIGATOR

Enrollment

2 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Masking Details: 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.
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Psychiatry

Study Record Dates

First Submitted

January 30, 2020

First Posted

January 31, 2020

Study Start

October 15, 2020

Actual (reported)

Study Stopped

Light at Night Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Healthy controls

Bipolar I disorder

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Healthy controls

Bipolar I disorder

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations