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Blue-Blocking Sunglasses for Mania (OSAN Trial)

N/A
Recruiting
Led By Jess G Fiedorowicz, MD, PhD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be able to read and understand English or French
Be 18 to 70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up inferred from melatonin/cortisol curves, rest-activity cycle (wrist actigraphy), heart rate/temperature monitoring, electroencephalography
Awards & highlights

OSAN Trial Summary

This trial will study whether blue-blocking glasses help people with mania.

Who is the study for?
This trial is for adults aged 18-70 with manic symptoms from bipolar disorder, who can understand English or French and give informed consent. It's not for those with severe eye issues, traumatic brain injury, sleep apnea, or taking melatonin supplements.Check my eligibility
What is being tested?
The study tests if wearing blue-blocking glasses can help manage mania by mimicking dark therapy effects without the impracticality of staying in a dark room. Participants will be randomly given either blue-blocking glasses or lightly-tinted glasses to compare outcomes.See study design
What are the potential side effects?
Since this treatment involves non-invasive blue-blocking glasses, there are no direct medical side effects like those associated with medications. However, individual comfort levels with wearing the glasses may vary.

OSAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can read and understand English or French.
Select...
I am between 18 and 70 years old.

OSAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week one; two week (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week one; two week (end of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Young Mania Rating Scale
Secondary outcome measures
Amount of antipsychotic (in chlorpromazine equivalents) and benzodiazepine used (in lorazepam equivalents)
Change Circadian Rhythms
Change in Altman Self-Rating Mania Scale - 5-Item Self Rating Mania Scale (ASRM)
+11 more

OSAN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Blue-blocking glassesExperimental Treatment1 Intervention
Participants will wear orange/amber colored lenses that filter wavelengths of light in the blue spectrum while awake from 6 p.m. to 8 a.m.
Group II: Lightly-tinted glassesPlacebo Group1 Intervention
This control will involve glasses that selectively filter short wavelength (e.g., ultraviolet), but not visible blue light during the same time window. Participants will wear these glasses while awake from 6 p.m. to 8 a.m.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blue-blocking glasses
2021
N/A
~140

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,640 Total Patients Enrolled
Jess G Fiedorowicz, MD, PhDPrincipal InvestigatorHead and Chief, Department of Mental Health, The Ottawa Hospital
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

Blue-blocking glasses Clinical Trial Eligibility Overview. Trial Name: NCT05206747 — N/A
Mania Research Study Groups: Blue-blocking glasses, Lightly-tinted glasses
Mania Clinical Trial 2023: Blue-blocking glasses Highlights & Side Effects. Trial Name: NCT05206747 — N/A
Blue-blocking glasses 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206747 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I take part in this medical experiment?

"This study seeks 51 individuals with mania aged between 18 and 70. To be eligible, subjects must: sign off on the granting of medical records to investigators; be literate in either English or French; comprehend the risks associated with participation as outlined by the consent form; (Sub-study only): meet safety requirements for any applicable devices according to their user manuals."

Answered by AI

Are there any open spots left in this experiment?

"As per information available online, this research study is actively searching for participants. It was originally published on September 7th 2022 and last amended on the 13th of that same month."

Answered by AI

Is the age limit for enrollees in this clinical trial above 25 years?

"According to the given inclusion criteria, potential participants should span 18 - 70 years of age. For those younger than 18 and older than 65, there are 52 studies and 200 respectively."

Answered by AI

How many people are participating in this clinical research endeavor?

"Affirmative. The information published on clinicaltrials.gov makes it clear that this medical trial is presently seeking participants, first posted on September 7th 2022 and most recently edited the following week. There are a total of 51 patients needed between 2 different sites."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Ottawa Sunglasses at Night for Mania Study
2022. "Ottawa Sunglasses at Night for Mania Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05206747.
All > Bipolar Disorder
~20 spots leftby Apr 2025
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