TY - JOUR

T1 - BLUES - stabilizing mood and sleep with blue blocking eyewear in bipolar disorder - a randomized controlled trial study protocol

AU - Madsen, Helle Østergaard

AU - Hageman, Ida

AU - Martiny, Klaus

AU - Faurholt-Jepsen, Maria

AU - Kolko, Miriam

AU - Henriksen, Tone E G

AU - Kessing, Lars Vedel

N1 - Publisher Copyright: © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

PY - 2023

Y1 - 2023

N2 - INTRODUCTION: Chronotherapeutic interventions for bipolar depression and mania are promising interventions associated with rapid response and benign side effect profiles. Filtering of biologically active short wavelength (blue) light by orange tinted eyewear has been shown to induce antimanic and sleep promoting effects in inpatient mania. We here describe a study protocol assessing acute and long-term stabilizing effects of blue blocking (BB) glasses in outpatient treatment of bipolar disorder.PATIENTS AND METHODS: A total of 150 outpatients with bipolar disorder and current symptoms of (hypo)-mania will be randomized 1:1 to wear glasses with either high (99%) (intervention group) or low (15%) (control group) filtration of short wavelength light (<500 nm). Following a baseline assessment including ratings of manic and depressive symptoms, sleep questionnaires, pupillometric evaluation and 48-h actigraphy, participants will wear the glasses from 6 PM to 8 AM for 7 consecutive days. The primary outcome is the between group difference in change in Young Mania Rating Scale scores after 7 days of intervention (day 9). Following the initial treatment period, the long-term stabilizing effects on mood and sleep will be explored in a 3-month treatment paradigm, where the period of BB treatment is tailored to the current symptomatology using a 14-h antimanic schedule during (hypo-) manic episodes (BB glasses or dark bedroom from 6 PM to 8 AM) and a 2-h maintenance schedule (BB glasses on two hours prior to bedtime/dark bedroom) during euthymic and depressive states.The assessments will be repeated at follow-up visits after 1 and 3 months. Throughout the 3-month study period, participants will perform continuous daily self-monitoring of mood, sleep and activity in a smartphone-based app. Secondary outcomes include between-group differences in actigraphic sleep parameters on day 9 and in day-to-day instability in mood, sleep and activity, general functioning and objective sleep markers (actigraphy) at weeks 5 and 15.TRIAL REGISTRATION: The trial will be registered at www.clinicaltrials.gov prior to initiation and has not yet received a trial reference.ADMINISTRATIVE INFORMATION: The current paper is based on protocol version 1.0_31.07.23. Trial sponsor: Lars Vedel Kessing.

AB - INTRODUCTION: Chronotherapeutic interventions for bipolar depression and mania are promising interventions associated with rapid response and benign side effect profiles. Filtering of biologically active short wavelength (blue) light by orange tinted eyewear has been shown to induce antimanic and sleep promoting effects in inpatient mania. We here describe a study protocol assessing acute and long-term stabilizing effects of blue blocking (BB) glasses in outpatient treatment of bipolar disorder.PATIENTS AND METHODS: A total of 150 outpatients with bipolar disorder and current symptoms of (hypo)-mania will be randomized 1:1 to wear glasses with either high (99%) (intervention group) or low (15%) (control group) filtration of short wavelength light (<500 nm). Following a baseline assessment including ratings of manic and depressive symptoms, sleep questionnaires, pupillometric evaluation and 48-h actigraphy, participants will wear the glasses from 6 PM to 8 AM for 7 consecutive days. The primary outcome is the between group difference in change in Young Mania Rating Scale scores after 7 days of intervention (day 9). Following the initial treatment period, the long-term stabilizing effects on mood and sleep will be explored in a 3-month treatment paradigm, where the period of BB treatment is tailored to the current symptomatology using a 14-h antimanic schedule during (hypo-) manic episodes (BB glasses or dark bedroom from 6 PM to 8 AM) and a 2-h maintenance schedule (BB glasses on two hours prior to bedtime/dark bedroom) during euthymic and depressive states.The assessments will be repeated at follow-up visits after 1 and 3 months. Throughout the 3-month study period, participants will perform continuous daily self-monitoring of mood, sleep and activity in a smartphone-based app. Secondary outcomes include between-group differences in actigraphic sleep parameters on day 9 and in day-to-day instability in mood, sleep and activity, general functioning and objective sleep markers (actigraphy) at weeks 5 and 15.TRIAL REGISTRATION: The trial will be registered at www.clinicaltrials.gov prior to initiation and has not yet received a trial reference.ADMINISTRATIVE INFORMATION: The current paper is based on protocol version 1.0_31.07.23. Trial sponsor: Lars Vedel Kessing.

KW - BB-glasses

KW - Bipolar disorder

KW - blue blocking

KW - chronotherapeutics

KW - dark therapy

KW - maintenance

KW - mania

KW - RCT

U2 - 10.1080/07853890.2023.2292250

DO - 10.1080/07853890.2023.2292250

M3 - Journal article

C2 - 38109922

VL - 55

JO - Medical Biology

JF - Medical Biology

SN - 0785-3890

IS - 2

M1 - 2292250

ER -