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Breast CancerICANSLEEPNCT05414357

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

A study testing Functional Magnetic Resonance Imaging at rest and in activation with attentional task in people with Breast Cancer and Sleep, run by Centre Francois Baclesse at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Sleep, Quality of Life
What is being tested?
Functional Magnetic Resonance Imaging at rest and in activation with attentional task
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesFrance
Study dates
20 Mar 2023to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • 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)

Who cannot join

  • 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
  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carine SEGURA-DJEZZAR, MD contact

+33 2 31 45 50 02

c.segura.djezzar@baclesse.unicancer.fr

France2 sites, 2 recruiting

  • Centre François Baclesse

    Caen, 14000

    Carine SEGURA-DJEZZAR, MD, +33 2 31 45 50 02, c.segura.djezzar@baclesse.unicancer.fr

    Carine SEGURA-DJEZZAR, MD

    Recruiting

  • Inserm-Ephe-Unicaen U1077

    Caen, 14000

    Fausto VIADER, PhD

    Fausto VIADER, PhD

    Not yet recruiting

Other trials in France

About this study

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.

Being tested
Functional Magnetic Resonance Imaging at rest and in activation with attentional task
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Spatial memory task, Cognitive battery, quality of life questionnaires

    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)
Study groups in NCT05414357
Study groupRoleWhat they receive
Patients with chemotherapy or radiotherapyExperimentalNot described
Receives: Diagnostic Test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task
cancer-free volunteersActive comparatorNot described
Receives: Diagnostic Test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 6 months

  2. Amplitude of activity-rest rhythm measured with actimeter

    Measured: At 6 months

  3. Acrophase of activity-rest rhythm measured with actimeter

    Measured: At 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start20 Mar 2023
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05414357
Sponsor's protocol ID
2022-A00437-36
Acronym
ICANSLEEP
Status last verified
Sep 2026
First submitted
30 May 2022
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Galin M, de Girolamo L, Clarisse B, Segura-Djezzar C, Glockner F, Elia C, Rehel S, Clochon P, Doidy F, Chavant J, Etard O, Viader F, Grellard JM, Lequesne J, Joly F, Eustache F, Martin T, Giffard B, Quarck G, Perrier J. Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol. PLoS One. 2024 Jul 31;19(7):e0306462. doi: 10.1371/journal.pone.0306462. eCollection 2024.

    PubMed 39083526

  • Elia C, de Girolamo L, Clarisse B, Galin M, Rehel S, Clochon P, Doidy F, Segobin S, Viader F, Naveau M, Delcroix N, Segura-Djezzar C, Grellard JM, Lequesne J, Etard O, Martin T, Quarck G, Eustache F, Joly F, Giffard B, Perrier J. Effects of sleep disturbances and circadian rhythms modifications on cognition in breast cancer women before and after adjuvant chemotherapy: the ICANSLEEP-1 protocol. BMC Cancer. 2023 Dec 1;23(1):1178. doi: 10.1186/s12885-023-11664-x.

    PubMed 38041077

Questions about this trial

What is this clinical trial studying?

A study testing Functional Magnetic Resonance Imaging at rest and in activation with attentional task in people with Breast Cancer and Sleep, run by Centre Francois Baclesse at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carine SEGURA-DJEZZAR, MD (+33 2 31 45 50 02, c.segura.djezzar@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05414357, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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