[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557963":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":63,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":32,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":95,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Colorado, Colorado Springs","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Smart Bassinet (SB)","EXPERIMENTAL","The SB responds to an infant who is fussing or crying by initiating \"swaying\" movement and \"shushing\" sounds with white noise that incrementally increase until the infant calms or the caregiver shuts it off. It will help babies transition into life outside of the womb with ease, enabling them to feel safe and secure, which translates to more sleep.",[13],"Device: Smart Bassinet",{"label":15,"type":16,"description":17,"interventionNames":18},"HALO Bassinet (TAU)","ACTIVE_COMPARATOR","The HALO is a commercially available bassinet that does not have any robotic\u002Fresponsive actions incorporated within it.",[19],"Device: HALO",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Smart Bassinet","The SNOO will respond to a crying or fussing infant in order to soothe and calm it down.",[9],[27],"Robotic, responsive bassinet, SNOO",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"HALO","The HALO is a commercially available bassinet",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Michele L Okun","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Michele L Okun, Ph.D.","CONTACT","412-302-8030","mokun@uccs.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University of Colorado Colorado Springs","RECRUITING","Colorado Springs","Colorado","80918","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-104.82136,38.83388,{"lat":56,"lon":55},[59,60],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},{"name":39,"role":36,"phone":32,"phoneExt":32,"email":32},{"type":62,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[64,66],{"name":65,"class":6},"University of Virginia",{"name":67,"class":6},"Weill Medical College of Cornell University","100557963","improving-maternal-sleep-and-mental-health-100557963",false,"NCT06544941","Improving Maternal Sleep and Mental Health","Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet","SHINE","Inclusion Criteria:\n\n* Pregnant women with a singleton gestation who have a military affiliation\n* Ages 18-45 years\n* Ability to communicate during the screening process\n* Access to a computer, smart phone or tablet with internet service\n* Willing to use bassinet they are randomized to\n* Willing to travel to a local Quest for blood draw\n\nExclusion Criteria:\n\n* Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.\n* Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.\n* Under the age of 18 years or \\> 45 years. The goal is to include women of childbearing age.\n* Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.\n* Tobacco use (current). Smoking is associated with poor sleep and inflammation.\n* Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and\u002For obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.\n* Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.",true,"FEMALE","18 Years","45 Years",{"count":81,"type":82},342,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent\u002Fmitigate postpartum mood disorders by augmenting maternal sleep and\u002For enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual\u002Ftraditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nAim 1: Determine the effect of the SB on infant sleep and maternal sleep. \\[primary hypothesis or outcome measure 2\\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU.\n\nMilitary-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.",[88,89,90,91,92,93,94],"Postpartum Depression","Postpartum Anxiety","Sleep Disturbance","Infant Behavior","Maternal Behavior","Inflammation","Military Family",[96,97,98,99,100,101],"sleep","postpartum","intervention","inflammation","depression","anxiety","2025-02-06",{"date":104,"type":105},"2025-02-10","ACTUAL",{"date":107,"type":105},"2025-01-15",{"date":109,"type":82},"2028-06",{"name":5,"class":6},1]