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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorCentre Francois Baclesse

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged 39 to 69 years

A patient with localized breast cancer who has undergone surgery and may or may not be about to begin adjuvant treatment with chemotherapy or radiation therapy

Patient with education level 3 "end of primary education"

Patient with a good command of the French language

Disqualifiers

Patient with metastatic cancer

A patient with a primary cancer other than breast cancer and/or a history of treated cancer

Patient with a history of neurological damage

Patient with treated sleep apnea

Trial design

Design model

Parallel

Treatments tested in this trial

  • Functional Magnetic Resonance Imaging at rest and in activation with attentional task

    Diagnostic test

    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)

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Patients with chemotherapy or radiotherapyExperimental treatment 1 intervention
Group B: cancer-free volunteersActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At 6 months
2

Amplitude of activity-rest rhythm measured with actimeter

Time frame
At 6 months
3

Acrophase of activity-rest rhythm measured with actimeter

Time frame
At 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Centre Francois Baclesse

Lead sponsor

UMR_S 1077 Inserm-EPHE-Normandie Université

Collaborator