[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654226":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":59,"studyPopulation":52,"armGroups":60,"interventions":73,"overallOfficials":52,"centralContacts":52,"locations":52,"responsibleParty":83,"collaborators":52,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":52,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":116,"whyStopped":52,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":52},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Mean Richards-Campbell Sleep Questionnaire Total Score Across the Nights Following Stimulation Sessions 8-10","The Richards-Campbell Sleep Questionnaire (RCSQ) total score is calculated as the mean of five visual analog items and ranges from 0 to 100, with higher scores indicating better sleep. The primary outcome is the participant-level mean RCSQ total score obtained on the mornings after the nights following stimulation sessions 8, 9, and 10. At least two valid RCSQ nights are required to calculate the mean. The primary analysis will adjust for the mean RCSQ score from two consecutive valid baseline inpatient nights.","Mornings after the nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period",[14,18,22,25,28,32],{"measure":15,"description":16,"timeFrame":17},"Mean Total Sleep Time Measured by Lifesense HR6 Across the Nights Following Stimulation Sessions 8-10","Total sleep time (TST), measured in minutes by the Lifesense HR6 wearable device, will be averaged across valid device nights corresponding to the nights following stimulation sessions 8, 9, and 10. At least two valid device nights are required to calculate the participant-level mean TST.","Nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period",{"measure":19,"description":20,"timeFrame":21},"Generalized Anxiety Disorder-7 Score","Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, with total scores ranging from 0 to 21 and higher scores indicating greater symptom severity.","Baseline; 24-72 hours after the final stimulation session",{"measure":23,"description":24,"timeFrame":21},"Patient Health Questionnaire-9 Score","Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), with total scores ranging from 0 to 27 and higher scores indicating greater symptom severity.",{"measure":26,"description":27,"timeFrame":21},"EQ-5D-5L Health-Related Quality of Life","Health-related quality of life will be assessed using the Simplified Chinese version of the EQ-5D-5L. The China value-set utility index and EQ visual analog scale will be reported.",{"measure":29,"description":30,"timeFrame":31},"Proportion of Participants Completing at Least 8 of 10 Stimulation Sessions","Treatment-course completion will be defined as completion of at least 8 of the 10 planned active or sham stimulation sessions.","During the 10-14-day treatment period",{"measure":33,"description":34,"timeFrame":35},"Incidence of Adverse Events and Serious Adverse Events","Adverse events and serious adverse events will be recorded, including headache, scalp discomfort, dizziness, auditory discomfort, syncope, seizure, altered consciousness, new focal neurological deficits, vital-sign abnormalities, and interruptions related to study procedures.","From the first study-specific procedure through the final safety follow-up at postoperative Month 6",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Change in Prespecified EEG Frequency-Band Power","Change in prespecified 64-channel EEG frequency-band power from baseline to the post-treatment assessment will be evaluated using the predefined EEG analysis pipeline.","Baseline and 2-24 hours after stimulation session 10.",{"measure":42,"description":43,"timeFrame":40},"Change in Prespecified EEG Functional Connectivity","Change in prespecified functional connectivity derived from 64-channel EEG recordings from baseline to the post-treatment assessment will be evaluated using the predefined connectivity analysis pipeline.",{"measure":45,"description":46,"timeFrame":40},"Change in TMS-Evoked Cortical Response","Change in the prespecified TMS-evoked cortical response measured by TMS-EEG from baseline to the post-treatment assessment will be evaluated.",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":52,"timePerspective":52,"maskingInfo":53},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to active low-frequency rTMS or matched sham stimulation using a parallel-group design. Both groups will receive standard post-transplant care and the same inpatient sleep-support measures.","TREATMENT",null,{"masking":54,"maskingDescription":55,"whoMasked":56},"DOUBLE","Participants and outcome assessors will be masked to treatment allocation. The clinical care team, follow-up personnel, and statistical personnel will also remain masked whenever applicable. Because of device-operation requirements, the stimulation operator cannot be masked but will not participate in participant recruitment, primary outcome assessment, data entry, or statistical analysis. Emergency unmasking will be permitted only when knowledge of treatment allocation is necessary for urgent clinical management.",[57,58],"PARTICIPANT","OUTCOMES_ASSESSOR","This is an investigator-initiated, single-center, prospective, randomized, double-blind, parallel-group, sham-controlled trial conducted in adult recipients of a first single- or double-lung transplantation. Eligible participants will be enrolled during postoperative days 7-21 after clinical stabilization and must have evidence of in-hospital sleep disturbance, defined by a mean Richards-Campbell Sleep Questionnaire (RCSQ) score below 70 across two consecutive valid inpatient nights together with an Insomnia Severity Index (ISI) score of at least 8.\n\nParticipants will be randomized 1:1 to active or sham stimulation. Active treatment will consist of 1-Hz repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex at the F3 position, delivered at 100% of the resting motor threshold with 1,800 pulses per session over approximately 30 minutes. One session will be administered daily for a total of 10 sessions completed within 10-14 days. The sham group will undergo matched procedures using a dedicated sham coil or validated active\u002Fsham masking module with the same target, positioning, rhythm, sound, duration, and interaction procedures but without intended therapeutic cortical stimulation.\n\nParticipants and outcome assessors will remain blinded to treatment allocation. Clinical study personnel and statistical personnel will also remain blinded as specified in the protocol; stimulation operators cannot be blinded because of device-operation requirements but will not participate in recruitment, outcome assessment, data entry, or statistical analysis.\n\nThe primary outcome is the participant-level mean RCSQ total score obtained on the mornings after the nights following stimulation sessions 8, 9, and 10. The RCSQ ranges from 0 to 100, with higher scores indicating better sleep. The primary analysis will compare active and sham groups using an ANCOVA\u002Flinear-regression model adjusted for baseline RCSQ and prespecified randomization stratification factors.\n\nSecondary and exploratory outcomes include total sleep time measured using the Lifesense HR6 wearable device, ISI and other sleep measures, pain and opioid exposure, delirium, cognitive function, anxiety, depressive symptoms, fatigue, health-related quality of life, hospital and transplant-related outcomes, treatment feasibility, and adverse events. Resting-state 64-channel EEG and a prespecified TMS-EEG mechanistic substudy will explore changes in spectral power, alpha peak frequency, functional connectivity, network topology, and TMS-evoked cortical responses.\n\nAll participants will continue to receive standard post-transplant clinical care and standardized inpatient sleep-support measures. Necessary clinical treatment will take priority over study procedures, and the study intervention will not be used to delay treatment, rehabilitation, transfer, or discharge.",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Active Low-Frequency rTMS","EXPERIMENTAL","Participants assigned to this arm will receive active low-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex at the F3 position. Stimulation will be delivered at 1 Hz and 100% of the resting motor threshold, with 1,800 pulses per session over approximately 30 minutes, once daily for a total of 10 sessions completed within 10-14 days. Participants will continue to receive standard post-transplant care and standardized inpatient sleep-support measures.",[66],"Device: Active Low-Frequency Repetitive Transcranial Magnetic Stimulation",{"label":68,"type":69,"description":70,"interventionNames":71},"Sham rTMS","SHAM_COMPARATOR","Participants assigned to this arm will receive matched sham rTMS using a dedicated sham coil or validated active\u002Fsham masking module. The sham procedure will match the active treatment in target location, participant positioning, stimulation rhythm, sound, session duration, and study interaction procedures, but will not produce the intended therapeutic cortical stimulation. Participants will receive the same standard post-transplant care and inpatient sleep-support measures as the active rTMS group.",[72],"Device: Sham Repetitive Transcranial Magnetic Stimulation",[74,79],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":52},"DEVICE","Active Low-Frequency Repetitive Transcranial Magnetic Stimulation","Active rTMS will be delivered over the left dorsolateral prefrontal cortex at the F3 position using a figure-of-eight coil. Stimulation parameters are 1 Hz, 100% of the resting motor threshold, and 1,800 pulses per session over approximately 30 minutes. Treatment will be administered once daily for a total of 10 sessions completed within 10-14 days during the same hospitalization. No more than one study stimulation session will be administered on the same calendar day.",[62],{"type":75,"name":80,"description":81,"armGroupLabels":82,"otherNames":52},"Sham Repetitive Transcranial Magnetic Stimulation","Sham stimulation will be administered using a dedicated sham coil or validated active\u002Fsham masking module compatible with the locked study device. The target location, participant positioning, stimulation rhythm, sound, session duration, and interaction procedures will match active rTMS, but the sham procedure will not produce the intended therapeutic cortical stimulation. Sham stimulation will be administered once daily for a total of 10 sessions within 10-14 days.",[68],{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"PRINCIPAL_INVESTIGATOR","Jianxing He","PhD","100654226","phase-2-low-frequency-rtms-for-in-hospital-sleep-disturbance-after-lung-transplantation-100654226",false,"NCT07796425","Low-Frequency rTMS for In-Hospital Sleep Disturbance After Lung Transplantation","Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for In-Hospital Sleep Disturbance in Lung Transplant Recipients: A Randomized, Double-Blind, Sham-Controlled Trial","TMS-SLEEP-LTx","Inclusion Criteria:\n\nAge 18-70 years and able to provide independent written informed consent. First single- or double-lung transplantation. Postoperative day 7-21 at randomization; extubated for at least 48 hours, off ECMO, and off vasoactive medications for at least 24 hours.\n\nResting SpO2 ≥92% with stable oxygen requirements and able to complete study procedures in a seated or semi-recumbent position.\n\nNegative CAM\u002FCAM-ICU assessment during the preceding 24 hours, with clear consciousness and ability to complete sleep and cognitive assessments.\n\nStable trends in blood pressure, blood glucose, serum sodium, serum magnesium, and renal function; immunosuppressant concentrations considered acceptable by the transplant team.\n\nMean RCSQ score \\\u003C70 across two consecutive valid inpatient nights and baseline ISI score ≥8.\n\nAble to complete RCSQ, sleep diary, Lifesense HR6 monitoring, and 64-channel EEG assessments.\n\nExpected to remain hospitalized for at least 10 days and able to complete 10 stimulation sessions and the primary outcome assessment within 14 days.\n\nExclusion Criteria:\n\nUnable to provide valid informed consent, unwilling to participate, or unable to reliably complete the primary RCSQ assessment.\n\nHistory of epilepsy or unexplained seizures, active intracranial hemorrhage, significant cerebral edema, elevated intracranial pressure, recent stroke, or severe traumatic brain injury.\n\nIntracranial ferromagnetic metal, cochlear implant, deep brain stimulator, cardiac pacemaker\u002Fimplantable cardioverter-defibrillator, or other TMS-incompatible implant.\n\nSevere scalp infection, open wound, or inability to safely position the TMS coil or EEG cap.\n\nPregnancy or any condition considered by the investigator to pose unacceptable risk.\n\nRepeat lung transplantation, multiorgan transplantation, or current requirement for ECMO, mechanical ventilation, or vasoactive support.\n\nActive delirium, encephalopathy, posterior reversible encephalopathy syndrome (PRES), central nervous system infection, new focal neurological deficit, or seizure within the previous 30 days.\n\nSuspected calcineurin-inhibitor neurotoxicity, uncontrolled hypertension, clinically significant hypomagnesemia, hyponatremia, hypoglycemia, or other metabolic abnormality that may lower the seizure threshold.\n\nUncontrolled sepsis, active rejection requiring urgent intensified treatment, or rapidly deteriorating clinical status.","ALL","18 Years","70 Years",{"count":99,"type":100},152,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","This randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve in-hospital sleep quality in adult lung transplant recipients during early postoperative recovery.\n\nA total of 152 participants with in-hospital sleep disturbance after first single- or double-lung transplantation will be randomly assigned in a 1:1 ratio to active rTMS or matched sham stimulation. Active rTMS will target the left dorsolateral prefrontal cortex and will be delivered once daily for 10 sessions within 10-14 days.\n\nThe primary outcome is sleep quality measured using the Richards-Campbell Sleep Questionnaire during the nights following stimulation sessions 8, 9, and 10. The study will also evaluate wearable-device sleep measures, insomnia symptoms, pain, mood, cognitive and functional outcomes, safety, feasibility, and changes in brain activity measured by 64-channel electroencephalography.",[106,107],"Sleep Wake Disorders","Lung Transplantation",[109,110,111,112,113,114,115],"Repetitive Transcranial Magnetic Stimulation","rTMS","In-Hospital Sleep Disturbance","Lung Transplant Recipients","Dorsolateral Prefrontal Cortex","Richards-Campbell Sleep Questionnaire","64-Channel Electroencephalography","NOT_YET_RECRUITING","2026-08-31",{"date":119,"type":120},"2026-09-01","ACTUAL",{"date":117,"type":100},{"date":123,"type":100},"2028-08-31",{"name":5,"class":6}]