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

NCT ID: NCT05414357

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2027-09-30

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.

Conditions

Breast Cancer; Sleep; Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with chemotherapy

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Patients without chemotherapy

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

cancer-free volunteers

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Spatial memory task; Cognitive battery; quality of life questionnaires

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

UMR_S 1077 Inserm-EPHE-Normandie Université

UNKNOWN

Sponsor Role: collaborator

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre François Baclesse

Caen, , France

Site Status: RECRUITING

Inserm-Ephe-Unicaen U1077

Caen, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Carine SEGURA-DJEZZAR, MD

Role: CONTACT

c.segura.djezzar@baclesse.unicancer.fr

+33 2 31 45 50 02

Facility Contacts

Carine SEGURA-DJEZZAR, MD

Role: primary

c.segura.djezzar@baclesse.unicancer.fr

+33 2 31 45 50 02

Fausto VIADER, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 39083526 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38041077 (View on PubMed)

Other Identifiers

2022-A00437-36

Identifier Type: -

Identifier Source: org_study_id