[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624694":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":24,"id":62,"slug":24,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":24,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":84,"whyStopped":24,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Abant Izzet Baysal University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Acoustic Noise Masking Group","EXPERIMENTAL","Patients receiving environmental acoustic noise masking before and during nighttime sleep.",[13],"Behavioral: Acoustic Noise Masking Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Quiet Night Intervention Group","ACTIVE_COMPARATOR","Patients receiving a quiet night protocol including environmental noise and light reduction supported by earplugs and eye mask.",[19],"Behavioral: Quiet Night Intervention",{"label":21,"type":22,"description":23,"interventionNames":24},"Standard Care Control Group","NO_INTERVENTION","Patients receiving routine intensive care without additional sleep-promoting interventions.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"BEHAVIORAL","Acoustic Noise Masking Intervention","Environmental acoustic noise masking applied before and during nighttime sleep to reduce ambient ICU noise and support sleep continuity.",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Quiet Night Intervention","A quiet night protocol including environmental noise and light reduction supported by earplugs and an eye mask.",[15],[36],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Saadet Can Çiçek, Assoc. Prof., PhD","CONTACT","+90 506 284 6936","saadet.cancicek@ibu.edu.tr",[42],{"facility":43,"status":24,"city":44,"state":44,"zip":45,"country":46,"countryCode":24,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Bolu Izzet Baysal State Hospital","Bolu","14100","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],31.60611,40.73583,{"lat":51,"lon":50},[54],{"name":55,"role":38,"phone":56,"phoneExt":24,"email":57},"Nurcan Tekinalp, PhD Candidate","05422888208","ntekinalp14@gmail.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Saadet Can Çiçek","Associate Professor","100624694",false,"NCT07412964","The Effect of Pink Noise and the Quiet Night Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center Randomized Controlled Trial","The Effect of Pink-Brown Noise and the Quiet Time Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center, Randomized Controlled Trial","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Adults aged 18 years and older\n* Patients admitted to the adult intensive care unit\n* Expected ICU stay of at least one night\n* Ability to tolerate non-invasive sleep-related interventions (earplugs, eye mask, or acoustic masking)\n* Informed consent obtained from the patient or legally authorized representative\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Severe hearing impairment preventing use of acoustic interventions\n* Severe cognitive impairment or coma preventing sleep assessment\n* Use of continuous deep sedation\n* Diagnosed sleep disorders requiring pharmacological treatment\n* Skin conditions preventing use of wrist-worn actigraphy","ALL","18 Years",{"count":71,"type":72},18,"ESTIMATED","INTERVENTIONAL",[75],"NA","Sleep disruption is common in adult intensive care unit (ICU) patients and is often worsened by environmental noise and nighttime care activities. Poor sleep may negatively affect recovery and well-being.\n\nThis single-center, three-arm randomized controlled trial will evaluate the short-term effects of two non-pharmacological interventions-(1) pink-brown noise masking and (2) a quiet time intervention-on objective sleep parameters in adult ICU patients, compared with standard care.\n\nSleep outcomes will be measured using actigraphy-based wearable monitoring, including total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, and number of awakenings. Results are expected to support evidence-based nursing approaches to improve sleep in ICU patients.",[78,79],"Sleep Disturbance","Intensive Care Units",[79,81,82,83,78],"Noise","Sound Masking","Actigraphy","NOT_YET_RECRUITING","2026-04-17",{"date":87,"type":88},"2026-04-22","ACTUAL",{"date":90,"type":72},"2026-05",{"date":92,"type":72},"2027-01",{"name":5,"class":6},1]