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
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 contri...
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| Veröffentlicht in: | PloS one 2024-07, Vol.19 (7), p.e0306462 |
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| creator | Galin, Melvin de Girolamo, Laura Clarisse, Bénédicte Segura-Djezzar, Carine Glöckner, Franka Elia, Clara Réhel, Stéphane Clochon, Patrice Doidy, Franck Chavant, Julien Etard, Olivier Viader, Fausto Grellard, Jean-Michel Lequesne, Justine Joly, Florence Eustache, Francis Martin, Tristan Giffard, Bénédicte Quarck, Gaëlle Perrier, Joy |
| description | 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.
NCT05414357. |
| doi_str_mv | 10.1371/journal.pone.0306462 |
| format | Article |
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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.
NCT05414357.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0306462</identifier><identifier>PMID: 39083526</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Analysis ; Batteries ; Biology and Life Sciences ; Breast cancer ; Breast Neoplasms - complications ; Cancer patients ; Cancer therapies ; Care and treatment ; Chemotherapy ; Circadian rhythm ; Circadian Rhythm - physiology ; Circadian rhythms ; Cognition ; Cognition & reasoning ; Cognitive ability ; Corticosteroids ; Cortisol ; Disability ; Electric Stimulation Therapy - methods ; Ethical standards ; Female ; Hormones ; Humans ; Insomnia ; Medicine and Health Sciences ; Memory ; Memory tasks ; Mental task performance ; Middle Aged ; Quality of life ; Questionnaires ; Radiation therapy ; Randomized Controlled Trials as Topic ; Review boards ; Sleep ; Sleep - physiology ; Sleep disorders ; Sleep Initiation and Maintenance Disorders - physiopathology ; Sleep Initiation and Maintenance Disorders - therapy ; Spatial analysis ; Spatial memory ; Spatial Memory - physiology ; Stimulation ; Study Protocol ; Synchronism ; Synchronization ; Vestibular system ; Vestibule, Labyrinth - physiopathology</subject><ispartof>PloS one, 2024-07, Vol.19 (7), p.e0306462</ispartof><rights>Copyright: © 2024 Galin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</rights><rights>COPYRIGHT 2024 Public Library of Science</rights><rights>2024 Galin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2024 Galin et al 2024 Galin et al</rights><rights>2024 Galin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c572t-ab5d0c0b3c2611405b96104f6d225bd77e11344b42aa3cd764e5a2f47c9465a43</cites><orcidid>0000-0001-8360-0084 ; 0009-0005-9888-7483</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11290633/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11290633/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,861,882,2096,2915,23847,27905,27906,53772,53774,79349,79350</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39083526$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Dey, Avanti</contributor><creatorcontrib>Galin, Melvin</creatorcontrib><creatorcontrib>de Girolamo, Laura</creatorcontrib><creatorcontrib>Clarisse, Bénédicte</creatorcontrib><creatorcontrib>Segura-Djezzar, Carine</creatorcontrib><creatorcontrib>Glöckner, Franka</creatorcontrib><creatorcontrib>Elia, Clara</creatorcontrib><creatorcontrib>Réhel, Stéphane</creatorcontrib><creatorcontrib>Clochon, Patrice</creatorcontrib><creatorcontrib>Doidy, Franck</creatorcontrib><creatorcontrib>Chavant, Julien</creatorcontrib><creatorcontrib>Etard, Olivier</creatorcontrib><creatorcontrib>Viader, Fausto</creatorcontrib><creatorcontrib>Grellard, Jean-Michel</creatorcontrib><creatorcontrib>Lequesne, Justine</creatorcontrib><creatorcontrib>Joly, Florence</creatorcontrib><creatorcontrib>Eustache, Francis</creatorcontrib><creatorcontrib>Martin, Tristan</creatorcontrib><creatorcontrib>Giffard, Bénédicte</creatorcontrib><creatorcontrib>Quarck, Gaëlle</creatorcontrib><creatorcontrib>Perrier, Joy</creatorcontrib><title>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</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>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.
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Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>ProQuest Biological Science Journals</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest advanced technologies & aerospace journals</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials science collection</collection><collection>Publicly Available Content (ProQuest)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Galin, Melvin</au><au>de Girolamo, Laura</au><au>Clarisse, Bénédicte</au><au>Segura-Djezzar, Carine</au><au>Glöckner, Franka</au><au>Elia, Clara</au><au>Réhel, Stéphane</au><au>Clochon, Patrice</au><au>Doidy, Franck</au><au>Chavant, Julien</au><au>Etard, Olivier</au><au>Viader, Fausto</au><au>Grellard, Jean-Michel</au><au>Lequesne, Justine</au><au>Joly, Florence</au><au>Eustache, Francis</au><au>Martin, Tristan</au><au>Giffard, Bénédicte</au><au>Quarck, Gaëlle</au><au>Perrier, Joy</au><au>Dey, Avanti</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2024-07-31</date><risdate>2024</risdate><volume>19</volume><issue>7</issue><spage>e0306462</spage><pages>e0306462-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>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.
NCT05414357.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>39083526</pmid><doi>10.1371/journal.pone.0306462</doi><tpages>e0306462</tpages><orcidid>https://orcid.org/0000-0001-8360-0084</orcidid><orcidid>https://orcid.org/0009-0005-9888-7483</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2024-07, Vol.19 (7), p.e0306462 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_3086815739 |
| source | Open Access: PubMed Central; PLoS; MEDLINE; Full-Text Journals in Chemistry (Open access); DOAJ Directory of Open Access Journals; EZB Electronic Journals Library |
| subjects | Adult Analysis Batteries Biology and Life Sciences Breast cancer Breast Neoplasms - complications Cancer patients Cancer therapies Care and treatment Chemotherapy Circadian rhythm Circadian Rhythm - physiology Circadian rhythms Cognition Cognition & reasoning Cognitive ability Corticosteroids Cortisol Disability Electric Stimulation Therapy - methods Ethical standards Female Hormones Humans Insomnia Medicine and Health Sciences Memory Memory tasks Mental task performance Middle Aged Quality of life Questionnaires Radiation therapy Randomized Controlled Trials as Topic Review boards Sleep Sleep - physiology Sleep disorders Sleep Initiation and Maintenance Disorders - physiopathology Sleep Initiation and Maintenance Disorders - therapy Spatial analysis Spatial memory Spatial Memory - physiology Stimulation Study Protocol Synchronism Synchronization Vestibular system Vestibule, Labyrinth - physiopathology |
| title | 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 |
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