Life sciences · Interventional Study
ClinicalTrials.gov · September 30, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05414357). This is a study registration, not published results. Lead sponsor: Centre Francois Baclesse. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 75 participants (ESTIMATED). Conditions: Breast Cancer, Sleep, Quality of Life. Interventions: DIAGNOSTIC_TEST: Functional Magnetic Resonance Imaging at rest and in activation with attentional task. Primary outcome measures: Ratio of total sleep time to time spent in bed and the number of awakenings lasting more than one minute measured by polysomnography with actimeter , At 6 months; Amplitude of activity-rest rhythm measured with actimeter , At 6 months; Acrophase of activity-rest rhythm measured with actimeter , At 6 months. Brief 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.