[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522386":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":48,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Aalborg University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sleep fragmentation","EXPERIMENTAL","This subproject will be conducted in two sessions separated by three nights of sleep fragmentation. Each session will last approximately 2 hours. At the beginning of the first visit and after the last visit, 9 ml of blood will be drawn, and plasma will be isolated. After plasma isolation, the CRP concentration will be analyzed. In each forearm of the participant, a 4x4 cm area will be selected as Area of Interest (AOI). In these selected areas, itch will be induced in both sessions using histamine and cowhage and several tests will be conducted.",[13,14],"Other: Histamine","Other: Cowhage",[16,21],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"Histamine","Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds",[9],null,{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Cowhage","25 spicules will be inserted in the centre of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Silvia Kjær-Staal Lo Vecchio","CONTACT","+4521397785","slv@hst.aau.dk",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":30},"Silvia Lo Vecchio",[34],{"facility":5,"status":35,"city":36,"state":20,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Aalborg","9620","Denmark","DK",{"type":41,"coordinates":42},"Point",[43,44],9.9187,57.048,{"lat":44,"lon":43},[47],{"name":32,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":49,"investigatorFullName":32,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Assistant Professor","100522386","investigation-of-the-effects-of-sleep-fragmentation-on-itch-and-pain-sensitivity-100522386",false,"NCT06081946","Investigation of the Effects of Sleep Fragmentation on Itch and Pain Sensitivity","Investigation of the Effects of Sleep Provocations on Itch and Pain Sensitivity","Inclusion Criteria:\n\n* Healthy men and women\n* 18-60 years\n* Speak and understand English\n* Access to a smartphone during the experimental nights\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Drug addiction defined as any use of cannabis, opioids, or other drugs\n* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses (psychiatric diagnosis) that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia etc.)\n* Moles, wounds, scars, or tattoos in the area to be treated or tested\n* Current use of medications that may affect the trial such as antihistamines and pain killers.\n* Skin diseases\n* Consumption of alcohol or painkillers 24 hours before the study days and between these\n* Acute or chronic pain and itch\n* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)\n* Lack of ability to cooperate",true,"ALL","18 Years","60 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"NA","In This experiment, the investigators would like to test following hypotheses regarding the influence of sleep fragmentation on itch:\n\n* To investigate similarity and differences between itch and pain by comparing the effect of sleep deprivation in them.\n* To evaluate the inflammatory state induced by sleep fragmentation via the analysis of C-reactive protein (CRP) levels from blood samples.\n* To correlate the anxiety and depression scores (evaluated through questionnaires) with itch and pain sensitivity and evaluate how they are affected by sleep fragmentation.",[17,22,70],"Sleep Fragmentation","2024-11-20",{"date":73,"type":74},"2024-11-22","ACTUAL",{"date":76,"type":74},"2023-12-15",{"date":78,"type":64},"2026-12-31",{"name":5,"class":6},1]