[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593059":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":57,"studyPopulation":51,"armGroups":58,"interventions":76,"overallOfficials":98,"centralContacts":102,"locations":111,"responsibleParty":138,"collaborators":51,"id":140,"slug":51,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":51,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":51,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":51,"overallStatus":159,"whyStopped":51,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Blekinge Institute of Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":43},[9,13,16,19,22,25,28],{"measure":10,"description":11,"timeFrame":12},"Sleep architecture REM","Sleep architecture containing sleep stages REM - Random eye movement stage.","Nightly during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant.",{"measure":14,"description":15,"timeFrame":12},"Sleep architecture Deep Sleep","Sleep architecture containing sleep stages, Deep sleep",{"measure":17,"description":18,"timeFrame":12},"Sleep architecture, light sleep","Sleep architecture containing sleep stages, light sleep",{"measure":20,"description":21,"timeFrame":12},"Sleep latency (time to fall asleep)","time to fall asleep- through EEG headband",{"measure":23,"description":24,"timeFrame":12},"Total sleep time (TST)","Total amount or duration of sleep",{"measure":26,"description":27,"timeFrame":12},"Sleep efficiency (SE)","Sleep efficiency (SE)- Sleep efficiency is the percentage of time in bed actually spent sleeping. It is calculated by dividing total sleep time by total time spent in bed and multiplying by 100. Higher sleep efficiency suggests less wakefulness during the night and better overall sleep quality.",{"measure":29,"description":30,"timeFrame":12},"Wake up after sleep onset (WASO).","Wake up after sleep onset (WASO).WASO measures the cumulative amount of time a participant spends awake after initially falling asleep, until final morning awakening. Elevated WASO values may indicate fragmented or disrupted sleep, which can negatively affect sleep quality and daytime functioning.",[32,36,40],{"measure":33,"description":34,"timeFrame":35},"Subjective sleep quality","Single-Item Sleep Quality Scale. Range 0 (Terrible) to 10 (Excellent)","Each morning from Day 1 through Day 35 after each participant's enrollment, covering all intervention and washout weeks; up to 5 weeks per participant",{"measure":37,"description":38,"timeFrame":39},"Comfort of using the EEG headband","How comfortable do you find wearing the EEG headband at night?\n\n1. \\- Very uncomfortable\n2. \\- Slightly uncomfortable\n3. \\- Neither comfortable nor uncomfortable\n4. \\- Somewhat comfortable\n5. \\- Very comfortable","Each morning during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant",{"measure":41,"description":42,"timeFrame":39},"Intervention Adherence","Participants will be asked whether they were able to complete the assigned evening activity the previous night. If the answer is \"yes,\" they will also report how long they engaged in the intervention (in minutes). This self-report measure will help evaluate the feasibility and real-world compliance with each intervention condition.",[44],{"measure":45,"description":46,"timeFrame":47},"Baseline survey","Before the first intervention phase, participants complete a baseline survey assessing:\n\nSociodemographic characteristics (Gender, Living status, economic situation, working status, how many hours do you work, education status).\n\nSubjective sleep health (SATED 3 item likert scale instrument with five questions).\n\nSleeping habits (sleep medication use?, Sleep-schedule regularity,Daytime napping, Evening screen exposure, Sleep disruption by physical symptoms (pain,itching), Sleep disruption by psychological factors, Night-time technology use, Nocturia).\n\nChronotype (The reduced Morningness-Eveningness Questionnaire), general health status (0 bad to 4 excellent).\n\nTechnology use (On average, how often have you used the INTERNET on your computer, tablet and smartphone in the last three months?).","Baseline (Day 0, at enrollment; one-time survey)",{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":51,"timePerspective":51,"maskingInfo":53},"RANDOMIZED","CROSSOVER",null,"SCREENING",{"masking":54,"maskingDescription":51,"whoMasked":55},"SINGLE",[56],"OUTCOMES_ASSESSOR","This study will compare the effects of watching calming (nature documentaries), playing exciting digital games like Ruzzle, and reading a physical book on older adults' subjective and objective sleep quality. This will be a randomized crossover trial. The investigators will exclude participants with diagnosed sleep disorders, Severe cognitive impairment, Use of sleep-affecting medications such as melatonin or benzodiazepines, or Irregular sleep schedules. A sample size of approximately 50 participants (49-51) will be recruited.\n\nAll the participants will have all three intervention periods with washout periods in between. During every intervention week, participants will fill out a quick nightly log about their sleep and what tech they used (smartphone, tablet, or a laptop\u002Fcomputer). During sleep, they will wear a comfy EEG headband measuring their sleep stages.\n\nBecause everyone eventually does all three conditions, the investigators can compare each person's own results and get more precise answers with fewer people.\n\nThe investigators will analyze the data and perform a statistical analysis. The study will be reported in the manuscript and published in a reputable journal.",[59,65,70],{"label":60,"type":61,"description":62,"interventionNames":63},"Calming Digital Content","EXPERIMENTAL","Participants will watch calming digital content - specifically, nature documentaries narrated by Sir David Attenborough - for 30 to 60 minutes within one hour before bedtime. Sleep outcomes will be assessed using EEG recordings and subjective sleep quality logs.",[64],"Behavioral: Calming digital content",{"label":66,"type":61,"description":67,"interventionNames":68},"Exciting Digital Content","Participants will engage with exciting digital content by playing the word-based game Ruzzle for 30 to 60 minutes within one hour before bedtime. Sleep outcomes will be evaluated using EEG measurements and subjective sleep assessments.",[69],"Behavioral: Exciting Digital Content",{"label":71,"type":72,"description":73,"interventionNames":74},"Non-Digital Pre-Sleep Activity","ACTIVE_COMPARATOR","Participants will engage in a non-digital activity by reading a physical, non-fiction book of their choice for 30 to 60 minutes within one hour before bedtime. No digital screens will be used. Sleep outcomes will be monitored via EEG data and self-reported sleep quality measures.",[75],"Behavioral: Non-digital book reading",[77,85,92],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"BEHAVIORAL","Calming digital content","Participants watch a curated selection of soothing documentaries narrated by Sir David Attenborough for 30-60 minutes each evening during one hour before bedtime.",[60],[83,84],"digital","nature documentary",{"type":78,"name":66,"description":86,"armGroupLabels":87,"otherNames":88},"Participants engage with the interactive word-based game Ruzzle for 30-60 minutes each evening during one hour before bedtime, designed to provide mental stimulation.",[66],[89,90,91],"Digital","Ruzzle","Game",{"type":78,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Non-digital book reading","Participants read a non-fiction book of their choice for the same duration, avoiding all digital screens during one hour before bedtime before bedtime.",[71],[97],"book reading",[99],{"name":100,"affiliation":5,"role":101},"Peter Anderberg, PhD","PRINCIPAL_INVESTIGATOR",[103,107],{"name":100,"role":104,"phone":105,"phoneExt":51,"email":106},"CONTACT","+46734223736","peter.anderberg@bth.se",{"name":108,"role":104,"phone":109,"phoneExt":51,"email":110},"Sarah Nauman Ghazi, MD| M.Sc. | Fil. Licentiate","+46706604935","sarah.n.ghazi@bth.se",[112],{"facility":5,"status":51,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Karlskrona","Blekinge County","SE-371 79","Sweden","SE",{"type":119,"coordinates":120},"Point",[121,122],15.58661,56.16156,{"lat":122,"lon":121},[125,129,132,134,136],{"name":126,"role":104,"phone":127,"phoneExt":51,"email":128},"Johan Sanmartin Berglund","+46 (0) 455-385471","johan.sanmartin.berglund@bth.se",{"name":130,"role":131,"phone":51,"phoneExt":51,"email":51},"Sarah Nauman Ghazi","SUB_INVESTIGATOR",{"name":133,"role":131,"phone":51,"phoneExt":51,"email":51},"Anders Behrens",{"name":135,"role":131,"phone":51,"phoneExt":51,"email":51},"Joakim Niklasson",{"name":137,"role":131,"phone":51,"phoneExt":51,"email":51},"Jessica Berner",{"type":139,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100593059",false,"NCT07001514","Evening Screen Content and Sleep Architecture in Older Adults: Crossover RCT","The Effect of Evening Technology Use With Calming vs. Exciting Content on Sleep Architecture in Older Adults: A Crossover Randomized Controlled Trial","Inclusion Criteria\n\n1. Age 60 - 75 years\n2. Regular evening use of digital devices (e.g., smartphones or tablets)\n3. Willing and able to wear an EEG headband for sleep monitoring throughout the intervention\n\nExclusion Criteria:\n\n1. Diagnosed sleep disorder\n2. Severe cognitive impairment\n3. Current use of medications that significantly influence sleep (e.g., melatonin, benzodiazepines)",true,"ALL","60 Years","75 Years",{"count":151,"type":152},50,"ESTIMATED","INTERVENTIONAL",[155],"NA","Title\n\nThe Effect of Evening Technology Use with Calming vs. Exciting Content on Sleep Architecture in Older Adults: A Crossover Randomized Controlled Trial\n\nBackground\n\nThe study explores how evening use of digital devices with different types of content (calming vs. exciting) affects sleep in older adults. While technology's effects on sleep have been studied in younger populations, its specific impacts on older adults remain under-researched. This study fills that gap by focusing on subjective and objective sleep measures.\n\nObjectives and Research Questions\n\nObjective: Compare the effects of calming digital content, exciting digital content, and non-digital activities on sleep architecture.\n\nKey Questions:\n\nHow does content type impact sleep architecture and quality? Does calming content lead to better sleep outcomes than exciting content? Are there subjective differences in sleep quality across conditions?",[158],"Sleep","NOT_YET_RECRUITING","2025-05-31",{"date":162,"type":163},"2025-06-03","ACTUAL",{"date":165,"type":152},"2025-08",{"date":167,"type":152},"2026-12",{"name":5,"class":6},1]