[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533438":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":18,"centralContacts":31,"locations":37,"responsibleParty":61,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":18,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Open label placebo only arm","EXPERIMENTAL","Participants who are assigned to the OLP group will be given a bottle of OLP pills. They will be asked to take one pill per day for 45 days. They will be introduced to placebo effects and the therapeutic potential of using open-label placebo for chronic pain management and sleep improvement.",[13],"Dietary Supplement: Open-label placebo pills",{"label":15,"type":16,"description":17,"interventionNames":18},"Wait-list arm","NO_INTERVENTION","Participants in the wait-list group will not receive OLP pills until the end of the 45-day monitoring period. Therefore, the 45 days without OLP will serve as an no intervention comparators relative to the OLP group.",null,{"label":20,"type":10,"description":21,"interventionNames":22},"Open label placebo + expectation management","Participants assigned to this arm will complete an 1 hour discussion about their expectations towards open-label placebo intervention. After that, they will continue with the 2-day run-in period and 45-day intervention. They will be asked to take 1 open-label placebo pill per day, for a total of 45 days.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DIETARY_SUPPLEMENT","Open-label placebo pills","The placebo pills in this study are empty capsules without any ingredients inside. The capsules are made of microcrystalline cellulose.",[20,9],[30],"Zeebo pills",[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Yang Wang, PhD","CONTACT","4107067824","yang.wang@umaryland.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Maryland Baltimore School of Nursing","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-76.61219,39.29038,{"lat":50,"lon":49},[53,55,59],{"name":33,"role":34,"phone":54,"phoneExt":18,"email":36},"410-706-7824",{"name":56,"role":34,"phone":57,"phoneExt":18,"email":58},"Rachel Massalee, MS","4107065975","rmassalee@umaryland.edu",{"name":33,"role":60,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100533438","placebo-impacts-sleep-and-pain-modulation-in-chronic-pain-100533438",false,"NCT06225817","Placebo Impacts Sleep and Pain Modulation in Chronic Pain","The Impact of Open-label Placebo on Sleep and Pain Modulation","Inclusion Criteria:\n\n* Age ( 18-88 years old)\n* English speaker (written and spoken)\n* TMD for at least 3 months\n* Grade Chronic Pain Scale (GCPS) ≥1\n* Smartphone\u002Ftext messaging capability\n\nExclusion Criteria:\n\n* Present or past degenerative neuromuscular disease\n* Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years\n* Any personal (or family first degree) history of mania, schizophrenia, or other psychoses\n* Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.\n* Lifetime alcohol\u002Fdrug dependence or alcohol\u002Fdrug abuse in past 3 months\n* Pregnancy or breast feeding\n* Impaired or uncorrected hearing","ALL","18 Years","88 Years",{"count":74,"type":75},111,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this free-choice parallel design clinical trial is to examine the potential beneficial effects of using open-label placebo (OLP) in improving chronic pain related outcomes and sleep quality in people with temporomandibular disorders. This study will enroll a cohort of participants with temporomandibular disorders (TMD) which lasts for more than 3 months. The main questions it aims to answer are:\n\n1. Will participants with TMD be more likely to take open-label placebo pills if they are introduced to the effects of placebo (e.g., going through an expectation management session)?\n2. Will taking open-label placebo plus expectation management improve chronic pain related outcomes, such as chronic pain intensity, interference, levels of anxiety and depression, in the cohort of TMD?\n3. Will open-label placebo plus expectation management improve sleep quality in participants suffering from TMD?\n\nTo answer the above questions, participants with TMD will be randomly assigned to three groups: 1. Open-label placebo plus expectation management group, where participants will complete a 1-hour discussion session about their expectations toward open-lable placebo intervention, and then take 1 open-labe placebo pill per day for a total of 45 days. 2. Open-label placebo only group where participants will be asked to take open-label placebo pills, one pill per day, for a total of 45 days. 3. standard of care group where participants will maintain their usual care without introducing open-label placebo to them during the 45 days monitoring. Researchers will compare the chronic pain intensity, interference, mood, anxiety, and sleep quality between the open-label placebo group and the wait-list group. Daily chronic pain will be measured using visual analog scale (VAS) ranging from 0=no pain at all to 100=maximum tolerable pain. Chronic pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and pain behavior. Anxiety and depression will be measured using PROMIS-anxiety, and PROMIS-depression scales respectively. Finally, sleep quality will be quantified using the objective measurement Motion Watch during the 45 days intervention and monitoring. In order to have a rigorous measurement of the baseline pain and sleep fluctuation, this study will include a 7-day phenotyping period before the starting of the 45-day intervention and monitoring. During the 7-day phenotyping period, participants will record their daily chronic pain and sleep quality using polysomnography.",[81,82],"Chronic Pain","Headache","2026-06-15",{"date":85,"type":86},"2026-06-17","ACTUAL",{"date":88,"type":86},"2025-04-21",{"date":90,"type":75},"2028-07-30",{"name":5,"class":6},1]