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NCT Number: NCT05414357

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse, Caen, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 39 to 69 years
  • Patient with operated localized breast cancer who may or may not be starting adjuvant chemotherapy
  • Patient with education level 3 "end of primary education"
  • Patient with a good command of the French language
  • Patient with access to the Internet from a computer at home
  • Patient having signed the consent to participate in the study
  • Patient with no pre-existing cognitive impairment at the time of cancer diagnosis
  • Patient with a sleep complaint (ISI > 7)

Exclusion criteria

  • Patient with metastatic cancer
  • Patient with a primary cancer other than breast cancer
  • Patient with a history of neurological damage
  • Patient with treated sleep apnea
  • Patient with drug use or alcohol abuse (≥3 drinks/day on average and/or >10 drinks/week)
  • Patient with a treatment that has not been stabilized for at least 3 months (hypnotics, antidepressants, anxiolytics)
  • Patient with a personality disorder and/or an evolving psychiatric pathology
  • Patient with a contraindication to MRI (claustrophobia, metallic objects in the body)
  • Patient with an uncorrected vision problem

Treatment and study plan

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)

Other names: Spatial memory task, Cognitive battery, quality of life questionnaires

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carine SEGURA-DJEZZAR, MD

CONTACT

[email protected]

+33 2 31 45 50 02

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • UMR_S 1077 Inserm-EPHE-Normandie Université

Registry information

Acronym: ICANSLEEP

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2022
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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