Actively Recruiting
RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Led by Aarhus University Hospital · Updated on 2025-01-08
84
Participants Needed
1
Research Sites
276 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
U
University of Aarhus
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Completed primary breast cancer treatment within 1 to 5 years (endocrine therapies allowed)
- Insomnia defined by an Insomnia Severity Index score greater than 10 and/or meeting DSM-5 criteria for Insomnia Disorder
- Cognitive impairment defined by significant difficulties in concentration or memory on the EORTC-QLQ-C30 or a FACT-Cog perceived cognitive impairment subscale score below 54
You will not qualify if you...
- Presence of sleep disorders other than insomnia that could affect sleep or cognitive function
- Use of drugs that may affect sleep or cognitive function (except endocrine therapies)
- Neurodegenerative or psychiatric disorders that may impact sleep or cognitive function
- Currently working night shifts
- Pregnancy or maternity leave
- Recurrence of breast cancer or diagnosis of new cancer
- Insufficient proficiency in Danish
- Substance abuse that could affect sleep or cognitive function
- Previous experience with cognitive behavioral therapy for insomnia (CBT-I)
- History of cancers other than breast cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Denmark
Actively Recruiting
Research Team
A
Ali Amidi
CONTACT
J
Julie K. Thomadsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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