Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504342
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-25
Brief Title:
Clocks in Sync - Circadian Rhythm and Bipolar Mania
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Trial of Time Restricted Eating to Support an Adaptive Innovative Clinical Trial of Combined Chronotherapies for Mania in Bipolar Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIS
Brief Summary:
The sleep-wake cycle is severely disrupted during an episode of mania Often mania is treated with medications that can come with significant side effects Years of patient and family engagement with this population have revealed great interest in therapies targeting the sleep-wake cycle However there is still a lack of studies to support using these treatments for mania Patient partners are especially interested in two specific therapies for mania blue-blocking glasses and time-restricted eating because of their perceived feasibility and safety This pilot study will formally investigate the feasibility and effectiveness of these therapies for participants with mania an understudied population that faces many difficulties even after recovery The pilot study will collect interviews to identify barriers and ways to better support patients with mania using the therapies The study will also investigate how well these therapies can treat manic symptoms and restore sleep-wake cycles by tracking symptom rating scales and measuring activity levels Results from this pilot will be used to direct a larger study that will use a state-of-the art design to test the effectiveness of both therapies alone and in combination
Detailed Description:
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 1014 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
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 1014 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None