[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463037":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":61,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Walter Reed Army Institute of Research (WRAIR)","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects Who Received Acoustic Stimulation","EXPERIMENTAL","Following 40 hours of deprivation participants will sleep for approximately a four hour recovery sleep period and receive acoustic stimulation via the Philips SmartSleep during slow-wave sleep. They will then sleep for second night of four hour recovery sleep and receive acoustic stimulation via the Philips Smart Sleep device during slow-wave sleep again.",[13],"Device: Philips SmartSleep Acoustic Stimulation Device",{"label":15,"type":16,"description":17,"interventionNames":18},"Subjects Who Received Sham (no Acoustic Stimulation)","SHAM_COMPARATOR","Following 40 hours of deprivation participants will sleep for approximately a four hour recovery sleep period and receive Sham (no acoustic stimulation) via the Philips SmartSleep during slow-wave sleep. They will then sleep for second night of four hour recovery sleep and receive Sham (no acoustic stimulation) via the Philips Smart Sleep device during slow-wave sleep again.",[19],"Device: Sham (no Acoustic Stimulation)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Philips SmartSleep Acoustic Stimulation Device","Prior to bedtime on the first two recovery nights, a Philips SmartSleep device will be applied to the head of each subject. Subjects will receive acoustic stimulation during the four hours of sleep.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham (no Acoustic Stimulation)","Prior to bedtime on the first two recovery nights, a Philips SmartSleep device will be applied to the head of each subject. Subjects will receive Sham (no acoustic stimulation) during the four hours of sleep.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"John D Hughes, MD","CONTACT","301-319-3214","john.d.hughes4.ctr@mail.mil",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Walter Reed Army Institute of Research","RECRUITING","Silver Spring","Maryland","20910","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-77.02609,38.99067,{"lat":50,"lon":49},[53,57],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Ruthie Ratcliffe","301-319-3131","ruthie.h.ratcliffe.civ@mail.mil",{"name":58,"role":34,"phone":59,"phoneExt":26,"email":60},"Kajsa Carlsson","301-319-9287","kajsa.e.carlsson.ctr@mail.mil",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","JOHN D. HUGHES","Neurologist",[66],{"name":67,"class":68},"Philips Healthcare","INDUSTRY","100463037","acoustic-stimulation-during-restricted-sleep-after-sleep-deprivation-100463037",false,"NCT05309473","Acoustic Stimulation During Restricted Sleep After Sleep Deprivation","Slow-wave Sleep Enhancement Using Acoustic Stimulation to Facilitate Performance Recovery During Restricted Sleep After Sleep Deprivation","Inclusion Criteria:\n\n* Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)\n* Must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified.\n\nExclusion Criteria:\n\n* You must have learned English as your first language\n* You must have a body mass index (BMI) below 30 (this is a mathematical calculation of your height and weight)\n* You must not have current or a history of sleeping problems (for example, insomnia or sleep apnea), or symptoms that indicate a potential sleep disorder\n* You must get an average of 6-9 hours of sleep per night and maintain a normal sleep\u002Fwake schedule\n* You must not drink excessive amounts of caffeine, alcohol, or smoke cigarettes regularly\n* You must not be on certain medications (determined on a case by case basis)\n* You must test negative for illicit drugs\n* Women must not be pregnant or nursing\n* You must not be participating in another ongoing clinical trial\n* You must have a social security number or tax identification number in order to be paid for screening and participation in the study\n* You cannot have a history of the following conditions: Cardiovascular disease, a neurologic disorder, pulmonary disease requiring inhaler use, kidney disease or kidney abnormalities, liver disease of liver abnormalities, a history of psychiatric disorder requiring hospitalization or medication within the last two years or for a continuous period of more than 6 months in the last ten years",true,"ALL","18 Years","39 Years",{"count":81,"type":82},44,"ESTIMATED","INTERVENTIONAL",[85],"NA","The purpose of this study is to determine if brief sounds or tones presented within a restricted period of recovery sleep after a period of sleep deprivation will enhance restorative properties and improve performance during a subsequent period of wakefulness.",[88,89,90,91,92],"Sleep Deprivation","Sleep Restriction","Acoustic Stimulation","Performance","Alertness","2024-04-22",{"date":95,"type":96},"2024-04-23","ACTUAL",{"date":98,"type":96},"2022-03-14",{"date":100,"type":82},"2026-10",{"name":5,"class":6},1]