NCT05414357

Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Centre Francois Baclesse · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. Of the sleep disturbances experienced by patients, insomnia is the most common complaint. The prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). A recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. However, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. In particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. The links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. Finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.

Conditions

• Breast Cancer
• Sleep
• Quality of Life

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Functional Magnetic Resonance Imaging at rest and in activation with attentional task	Participants complete 3 successive assessments (T1: baseline, T2: at 6 months, T3: after galvanic vestibular stimulation). Assessments include: * Functional and Anatomic Magnetic Resonance Imaging at rest and in activation (only at T1 and T2). * Biological and physiological measurements * Spatial memory task * Cognitive battery * Questionnaires (sleep, quality of life)

Timeline

• Start date: 2023-03-20
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2022-06-10
• Last updated: 2025-09-22

Locations

2 sites across 1 country: France