Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Ottawa Hospital Research Institute
This pilot study will assess feasibility and preliminary data for a novel circadian intervention in a clinical population that has been understudied, patients dealing with manic episodes of bipolar disorder, with an equity, diversity, and inclusion plan to ensure broad demographic representation. The investigators' long-term goal is to conduct an innovative adaptive, 2x2 factorial study of these two interventions to determine the effects of each individual component and potential synergistic interactions. An adaptive design will allow interim analyses for sample size during which futility can also be assessed. This may potentially reduce cost and time of the later full trial, while ensuring that relevant findings are obtained. To inform a later 2x2 factorial study, researchers will need to gather data on the feasibility of time restricted eating in mania and identify any forms of support required to facilitate this chronotherapy. This is a randomized, parallel three group pilot study of blue-blocking glasses, time restricted eating, or blue-blocking glasses plus time-restricted eating in inpatients with mania. This project has three specific aims: Aim 1: To assess the feasibility of time restricted eating (10:14 of diurnal eating to nocturnal fasting based on patient partners' input) as an adjunctive treatment for mania in an inpatient setting. Feasibility will be assessed through monitoring of adherence and qualitative semi-structured interviews with patient participants when they exit the study and staff near the study end date. The purpose of these interviews is to identify any challenges or barriers in implementing this treatment, alone or in combination with blue blocking glasses, and what supports might be needed. The research team will also assess willingness to participate in the study through assessment of participation rates and reasons for accepting or declining. Aim 2: The investigators will secondarily compare differences between groups on the Young Mania Rating Scale (YMRS), which will be the primary outcome for the future trial. Aim 3 (exploratory): To explore changes in measures of circadian rhythms and sleep, including as measured with actigraphy and other non-invasive monitoring measures, with the interventions and in relation to recovery from mania.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
