Recruiting

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

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.

ClinicalTrials.gov IDNCT06553235

PhaseNA

Enrollment84

SponsorAarhus University Hospital

Age18 Years and older

SexFEMALE

I'm interested View official listing

Conditions studied

Insomnia, Cognitive Impairment, Breast Cancer

About this study

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.

Primary outcomes

Conners continuous performance test 3rd edition (Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33))
Insomnia Severity Index (ISI) (Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33))

Eligibility information

Inclusion Criteria: * Age ≥18 years * Have completed primary breast cancer (BC) treatment within 1-5 years (endocrine therapies allowed) * Insomnia: a score of \>10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder * Cognitive impairment: a score of "quite a bit" or "very much" on at least 1 of the 2 items measuring concentration and memory on The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30) and/or \<54 on the Cancer Therapy-Cognitive (FACT-Cog) perceived cognitive impairment (PCI) subscale Exclusion Criteria: * Other sleep disorders than insomnia that may confound sleep and/or cognitive function * Use of drugs impacting that may confound sleep and/or cognitive function (endocrine therapies allowed) * Neurodegenerative and psychiatric disorders that may confound sleep and/or cognitive function * Shift work * Pregnancy or maternity leave * Recurrence of BC or new cancer * Insufficient Danish proficiency * Substance abuse that may confound sleep and/or cognitive function * Previous experience with CBT-I * Other cancer than breast cancer

Study locations

Aarhus University Hospital, Aarhus N, Denmark

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-27.