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RECRUITING
NCT06553235
NA

RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention

Sponsor: Aarhus University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-12-06

Completion Date

2030-03-28

Last Updated

2025-01-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

CBT-I is a multi-component intervention consisting of sleep restriction, stimulus control therapy, relaxation therapy, cognitive therapy, and sleep hygiene education

BEHAVIORAL

Sleep hygiene education

\- Sleep hygiene education includes information on lifestyle factors (diet, exercise, substance use) and environmental variables (noise, light, temperature) affecting sleep quality.

Locations (1)

Aarhus University Hospital

Aarhus N, Denmark