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

NCT05414357 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-22

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • UMR_S 1077 Inserm-EPHE-Normandie Université

    collaborator UNKNOWN

  • Centre Francois Baclesse

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05414357 on ClinicalTrials.gov