Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553235
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
RESET-BRAIN REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RESET-BRAIN REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
RESET-BRAIN
Brief Summary:
The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia CBT-I can improve cognitive impairment in breast cancer survivors compared to an active control group sleep hygiene education The study will also explore if CBT-I is associated with changes in the brain and in inflammation The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years
Detailed Description:
The study is a randomized controlled trial comparing the effect of app-based cognitive behavioral therapy for insomnia CBT-I on cognitive function and insomnia to an active control group sleep hygiene Participants will be 84 breast cancer survivors who have completed primary treatment within 1-5 years and experience insomnia and cognitive impairment After baseline assessment participants will be randomized to either app-based CBT-I or sleep hygiene active control Both groups will undergo post-treatment assessments and 6-months follow-up assessments The primary outcomes will be cognitive impairment assessed with the Conners Continuous Performance Test CCPT and insomnia assessed with the Insomnia Severity Index ISI To explore potential neurobiological and inflammatory mechanisms structural magnetic resonance imaging MRI and inflammatory markers will be secondary outcomes To provide a broader insight into cognitive function participants will undergo further neuropsychological assessment with various standardized neuropsychological tests
The study has the following aims and hypotheses
PRIMARY AIM To investigate whether an app-based CBT-I is associated with improved sleep and cognitive function in BC survivors screened for insomnia and CI when compared with an active control group PRIMARY HYPOTHESIS Compared with an active control group CBT-I will be associated with a statistically significantly greater reduction in insomnia severity using the ISI and improvement of sustained attention and executive function assessed objectively using the CCPT Effects on secondary sleep outcomes will also be tested Exploratory hypothesis Improvements in sustained attention and executive function will be mediated by improved insomnia severity and sleep outcomes
SECONDARY AIM 1 To investigate whether CBT-I is associated with altered structural brain outcomes when compared with an active control group HYPOTHESIS Compared with an active control group CBT-I will be associated with changes in brain gray and white matter properties structural network topology as well as glymphatic function as operationalized with the diffusion tensor image along the perivascular space DTI-ALPS approach
SECONDARY AIM 2 To explore whether CBT-I is associated with changes in inflammatory immune function IL-1β IL-6 TNF-α IFN-γ when compared with an active control group HYPOTHESIS Compared with an active control group CBT-I will be associated with a statistically significantly greater reduction in inflammatory markers Improvements in sustained attention and executive function will be mediated by changes in inflammatory markers
The study has the following aims and hypotheses
PRIMARY AIM To investigate whether an app-based CBT-I is associated with improved sleep and cognitive function in BC survivors screened for insomnia and CI when compared with an active control group PRIMARY HYPOTHESIS Compared with an active control group CBT-I will be associated with a statistically significantly greater reduction in insomnia severity using the ISI and improvement of sustained attention and executive function assessed objectively using the CCPT Effects on secondary sleep outcomes will also be tested Exploratory hypothesis Improvements in sustained attention and executive function will be mediated by improved insomnia severity and sleep outcomes
SECONDARY AIM 1 To investigate whether CBT-I is associated with altered structural brain outcomes when compared with an active control group HYPOTHESIS Compared with an active control group CBT-I will be associated with changes in brain gray and white matter properties structural network topology as well as glymphatic function as operationalized with the diffusion tensor image along the perivascular space DTI-ALPS approach
SECONDARY AIM 2 To explore whether CBT-I is associated with changes in inflammatory immune function IL-1β IL-6 TNF-α IFN-γ when compared with an active control group HYPOTHESIS Compared with an active control group CBT-I will be associated with a statistically significantly greater reduction in inflammatory markers Improvements in sustained attention and executive function will be mediated by changes in inflammatory markers
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