Neuropsychology and Imaging of Human Memory Research Unit, GIP Cyceron-Normandy University-PSL-EPHE-INSERM-Caen University Hospital, Caen, France.
COMETE Research Unit, GIP Cyceron-Normandy University-PSL-EPHE-INSERM-Caen University Hospital, Caen, France.
PLoS One. 2024 Jul 31;19(7):e0306462. doi: 10.1371/journal.pone.0306462. eCollection 2024.
Patients with breast cancer (BC) exhibit circadian rhythm disruptions, mainly of rest-activity rhythm (RAR), of which sleep is an essential component, and cortisol rhythm. Sleep complaints such as insomnia and cognitive impairments are prevalent in BC. In general population, sleep is known to contribute greatly to cognition. Thus, improving RAR (and particularly sleep) could help limiting cognitive impairments in BC patients. It has recently been suggested that, in addition to its essential role in spatial memory, the vestibular system contributes to RAR synchronization. Its stimulation could therefore limit both sleep disturbances and spatial memory deficits in BC.
The main aim of the ICANSLEEP-2 study is to assess the effects of galvanic vestibular stimulation (GVS) on circadian rhythms. The secondary aim is to assess whether GVS improves sleep and spatial memory in BC patients.
Two groups with insomnia complaints (Insomnia Severity Index > 7) will be included: a patients' group with BC (n = 50) and a healthy control group without history of cancer (n = 25). There will be two assessment sessions, before and after 2 weeks of GVS. Patients will be randomly assigned to either a GVS group or a sham group (noneffective stimulation). Controls will receive GVS. GVS effects will be quantified and compared between groups. Assessments will include actigraphy, salivary cortisol, polysomnography, a cognitive test battery (including a computer-based task for spatial memory) and validated questionnaires (for psychological functioning and sleep complaints).
Current methods for improving sleep in BC have had controversial outcomes regarding sleep structure. We expect GVS to offer a new mean of directly targeting RAR disruptions in BC patients, with beneficial effects on sleep structure. Given the crucial impact of sleep on cognitive functioning, notably spatial memory, improving sleep of BC patients should enhance their cognitive functioning.
This study received ethical approval from the Ile de France IV institutional review board on 19 April 2022 (no. ID-RCB: 2022-A00437-36). The findings yielded by this protocol will be presented at various conferences and in peer-reviewed journals.
CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT05414357.
乳腺癌（BC）患者表现出昼夜节律紊乱，主要是休息-活动节律（RAR）紊乱，其中睡眠是一个重要组成部分，以及皮质醇节律。睡眠问题，如失眠和认知障碍，在 BC 患者中很常见。在一般人群中，睡眠对认知有很大的贡献。因此，改善 RAR（尤其是睡眠）可以帮助限制 BC 患者的认知障碍。最近有人提出，除了在空间记忆中起重要作用外，前庭系统还有助于 RAR 同步。因此，刺激前庭系统可以限制 BC 患者的睡眠障碍和空间记忆缺陷。
ICANSLEEP-2 研究的主要目的是评估电前庭刺激（GVS）对昼夜节律的影响。次要目的是评估 GVS 是否能改善 BC 患者的睡眠和空间记忆。
将纳入两组有失眠主诉的患者（失眠严重程度指数>7）：一组是有 BC 的患者组（n=50），另一组是没有癌症病史的健康对照组（n=25）。将进行两次评估，在 2 周的 GVS 前后。患者将被随机分配到 GVS 组或假刺激组（无效刺激）。对照组将接受 GVS。将对 GVS 效果进行量化，并在组间进行比较。评估将包括活动计、唾液皮质醇、多导睡眠图、认知测试套件（包括基于计算机的空间记忆任务）和经过验证的问卷（用于心理功能和睡眠主诉）。
目前改善 BC 睡眠的方法在睡眠结构方面存在争议。我们预计 GVS 将为改善 BC 患者的 RAR 紊乱提供一种新的方法，对睡眠结构有有益的影响。鉴于睡眠对认知功能的关键影响，特别是空间记忆，改善 BC 患者的睡眠应能提高他们的认知功能。
本研究于 2022 年 4 月 19 日获得法兰西岛第四区机构审查委员会的伦理批准（编号：ID-RCB：2022-A00437-36）。该方案产生的结果将在各种会议和同行评议期刊上发表。
NCT05414357。
