Status:
COMPLETED
Ottawa Sunglasses at Night for Mania Study
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Mania
Sleep
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Mania is a serious condition. Symptoms of mania include decreased sleep, increased energy, changes in mood, thinking, and behavior. Dark therapy, which involves placing patients in a dark room for 14 ...
Detailed Description
The purpose of this research project is to determine the effectiveness of blue-blocking glasses as adjunctive treatment for mania in bipolar disorder, assess circadian mechanisms, and provide informat...
Eligibility Criteria
Inclusion
- Be 18 to 70 years of age
- Have a Diagnostic and Statistical Manual of Mental Disorders (5th Edition) defined manic symptoms that persist beyond the physiological effects of a substance
- Be willing to have investigators obtain information from the treatment team and electronic medical record
- Participants must be able to read and understand English or French.
- Be willing and able to provide informed consent.
- (Sub-study only): Meet the safety specifications for the devices in the sub-study, according to their user manuals
Exclusion
- Have severe eye disease or trauma
- Have a history of traumatic brain injury.
- Have sleep apnea
- (Sub-study only): Have current exogenous melatonin intake
Key Trial Info
Start Date :
September 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05206747
Start Date
September 7 2022
End Date
September 9 2024
Last Update
January 17 2025
Active Locations (2)
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1
Ottawa Hospital Research Insitute
Ottawa, Ontario, Canada, K1Y 4E9
2
L'Hôpital Montfort
Ottawa, Ontario, Canada