Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-02 @ 5:53 PM
Study NCT ID:
NCT02302560
Status:
WITHDRAWN
Last Update Posted:
2018-04-18
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-11-24', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tissue Inhibitor of Metalloproteinases', 'timeFrame': 'At time of spinal anesthesia', 'description': 'Metalloproteinases (MMP-2 und MMP-9) from liquor samples (only in patients with spinal anesthesia).'}, {'measure': 'Metalloproteinases', 'timeFrame': 'At time of spinal anesthesia', 'description': 'Metalloproteinases (MMP-2 und MMP-9) from liquor samples (only in patients with spinal anesthesia).'}, {'measure': 'ASA (physical status classification system) status', 'timeFrame': 'At the beginning of the investigation'}, {'measure': 'Benzodiazepine premedication', 'timeFrame': 'At the beginning of the investigation'}], 'primaryOutcomes': [{'measure': 'Changes in prevalence of rapid eye movement sleep', 'timeFrame': 'Up to 36 hours', 'description': 'Changes in prevalence of rapid eye movement (REM) sleep in the preoperative night compared to the night following the first postoperative day, including potentially compensatory sleep during daytime after surgery.\n\nSleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 36 h (beginning in the preoperative evening, to be finished the morning of the second postoperative day).'}], 'secondaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': 'Up to 90 days after the operation', 'description': 'The ISI will be assessed by self-assessment questionnaire'}, {'measure': 'Malnutrition', 'timeFrame': 'Up to 90 days after the operation', 'description': 'Malnutrition Screening Tools'}, {'measure': 'Epsworth Sleepiness Scale', 'timeFrame': 'Up to 90 days after the operation', 'description': 'The ESS will be assessed by self-assessment questionnaire'}, {'measure': 'Postoperative Cognitive Dysfunction', 'timeFrame': 'Up to 90 days after the operation', 'description': 'Postoperative Cognitive Dysfunction will be measured at hospital discharge and at the 90th postoperative day.'}, {'measure': 'Depth of anesthesia', 'timeFrame': 'At time of surgery', 'description': 'Depth of anesthesia will be measured by processive Electroencephalography and Electromyography (EEG/EMG) -Data (SedLine®)'}, {'measure': 'Opioid requirements', 'timeFrame': 'Participants will be followed up for hospital stay an expected average of 7 days', 'description': 'Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Participants will be followed up for hospital stay an expected average of 7 days'}, {'measure': 'Pain', 'timeFrame': 'Participants will be followed up for hospital stay an expected average of 7 days', 'description': 'Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI)'}, {'measure': 'N-Methyl-D-aspartate (NMDA)-receptor autologous antibodies', 'timeFrame': 'Up to 90 days after the operation', 'description': 'Identification of NMDA-receptor autologous antibodies in blood serum and cerebrospinal fluid; the requested blood samples will be collected on the operation day, on the last day of hospitalisation and after 90 days. The requested liquor samples will be collected on the operation day (only in patients with spinal anesthesia).'}, {'measure': 'Inflammation parameters', 'timeFrame': 'Participants will be followed up for hospital stay an expected average of 7 days', 'description': 'Assessment of inflammation parameters by means of extended differential blood count (Sysmex) ; the requested blood samples will be collected on the preoperative day, on the day of the intervention, on the following day and on the last day of the hospitalisation'}, {'measure': 'Hemodynamic parameters', 'timeFrame': 'At time of surgery', 'description': 'Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor'}, {'measure': 'Changes in prevalence of rapid eye movement sleep', 'timeFrame': 'Up to 24 hours', 'description': 'REM-Sleep at operation day/night in comparison to preoperative night. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 24 h.'}, {'measure': 'Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)', 'timeFrame': 'Up to 24 hours', 'description': 'Slow wave sleep at operation day/night in comparison to preoperative night. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 24 h.'}, {'measure': 'Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)', 'timeFrame': 'Up to 36 hours', 'description': 'Changes in prevalence of slow-wave sleep in the preoperative night compared to the night following the first postoperative day, including potentially compensatory sleep during daytime after surgery.\n\nSleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 36 h (beginning in the preoperative evening, to be finished the morning of the second postoperative day).'}, {'measure': 'Postoperative complications', 'timeFrame': 'Participants will be followed up for hospital stay an expected average of 7 days', 'description': 'Including Severity of Delirium'}, {'measure': 'Transfusion requirements', 'timeFrame': 'Participants will be followed up for hospital stay an expected average of 7 days'}, {'measure': 'Catecholamine administration intra- und postoperative', 'timeFrame': 'Participants will be followed up for hospital stay an expected average of 7 days'}, {'measure': 'Severity of postoperative Delirium', 'timeFrame': 'Up to 36 hours', 'description': 'Delirium screening will be conducted preoperatively, one hour postoperative, the evening of operation day, and the following morning with the scoring devices of confusion assessment method (CAM), by confusion assessment method in the intensive care unit (CAM-ICU) or by Nursing Delirium Screening Scale (Nu-DESC)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Architecture']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective observational study is to investigate the changes in sleep architecture after a hip surgery and its potential association with postoperative delirium and postoperative cognitive dysfunctions respectively.', 'detailedDescription': 'Sleep research has confirmed the association of sleep (REM sleep and slow-wave sleep) with memory and cognitive function in general. There are changes in the quantity of REM sleep after certain forms of anesthesia, especially with barbiturate, as shown in mouse model. This study is designed to be the first explorative clinical studyl to measure changes in sleep architecture in surgical patients undergoing different types of anesthesia (general anesthesia and spinal anesthesia) and its potential associations with the development of postoperative delirium and postoperative cognitive dysfunction. Additionally, parameters will be collected, that from recent research are suspected to be reliable markers for systemic inflammation that might account for delirium and cognitive dysfunction after surgical interventions.\n\nPatients were stratified into two groups: age (≤ 65 years; \\> 65 years) and benzodiazepine premedication (yes/no).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with elective hip surgery (implementation or replacement of hip joint endoprothesis)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients with age 50 years and above\n* Intervention for hip joint endoprosthesis or replacement of endoprosthesis at the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum, Charité - University Medicine Berlin\n\nExclusion Criteria:\n\n* Lacking willingness to save and hand out data within the study\n* Missing informed consent of the patient\n* Participation in other prospective interventional study 10 days before study inclusion and during the study period\n* Patients with diagnosed and treated sleep disorders\n* Patients with psychiatric diseases\n* Patients with injuries or operations of the enteral tract and the esophagus respectively in the last four weeks before the hip surgery\n* Allergies to any substance of the electrode fixing material\n* Dermatoses in the area of the electrodes to be fixed'}, 'identificationModule': {'nctId': 'NCT02302560', 'briefTitle': 'Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)', 'orgStudyIdInfo': {'id': 'TepSo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with elective hip surgery', 'description': 'Patients with elective hip surgery (implementation or replacement of hip joint endoprotheses).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care Medicine Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. Dr. C. Spies', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}