Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271304
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-02-14
Brief Title:
Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder
Sponsor:
Mental Health Services in the Capital Region Denmark
Organization:
Mental Health Services in the Capital Region Denmark
Study Overview
Official Title:
Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLUES
Brief Summary:
The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light 500nm reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder
When in a hypomanic or manic phase participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days
After this initial intervention phase the eyewear is used daily for 3 months in either antimanic dose 14 hours or maintenance dose 2 hours before bedtime
When in a hypomanic or manic phase participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days
After this initial intervention phase the eyewear is used daily for 3 months in either antimanic dose 14 hours or maintenance dose 2 hours before bedtime
Detailed Description:
The study is a 2-arm single-blind RCT to assess the effects of blue blocking BB or clear glasses as an acute 7-day antimanic intervention and as a 3-month mood stabilizing maintenance intervention BB or clear glasses will be applied in addition to outpatient TAU for BD Participants will be recruited among patients treated for BD in specialized outpatient clinics within the Mental Health Center Copenhagen
The active intervention is BB-glasses that eliminate 99 of light with a wavelength below 530 nm whereas the clear glasses filter out only 15 of short wavelength light low filtration LF
Participation includes 3 months use of the designated eyewear along with daily electronic self-monitoring of mood sleep and activity as well as participation in a 2-day baseline assessment and a total of 3 follow-up visits including clinical assessment interview questionnaires and actigraphic 48 hours and pupillometric assessments at day 9 week 5 and week 15
Participants will be included during hypomanic or manic state and begin treatment with an antimanic dosage of 14 hours 6 PM - 8 AM for 7 consecutive days Subsequently during the 3-month follow-up period the dosage hours using the glasses can be adjusted according to the current state with use for 14 hours during hypomanicmanic phases and 2 hours before bedtime during euthymic and depressive states
Outcome assessors will be blinded to the treatment assignment and patients will be informed that they are randomized to eyewear with either high or low filtration of light Patients will be randomized on a 11 basis with stratification according to sex and outpatient clinic
The active intervention is BB-glasses that eliminate 99 of light with a wavelength below 530 nm whereas the clear glasses filter out only 15 of short wavelength light low filtration LF
Participation includes 3 months use of the designated eyewear along with daily electronic self-monitoring of mood sleep and activity as well as participation in a 2-day baseline assessment and a total of 3 follow-up visits including clinical assessment interview questionnaires and actigraphic 48 hours and pupillometric assessments at day 9 week 5 and week 15
Participants will be included during hypomanic or manic state and begin treatment with an antimanic dosage of 14 hours 6 PM - 8 AM for 7 consecutive days Subsequently during the 3-month follow-up period the dosage hours using the glasses can be adjusted according to the current state with use for 14 hours during hypomanicmanic phases and 2 hours before bedtime during euthymic and depressive states
Outcome assessors will be blinded to the treatment assignment and patients will be informed that they are randomized to eyewear with either high or low filtration of light Patients will be randomized on a 11 basis with stratification according to sex and outpatient clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None