Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 8:09 AM
Study NCT ID:
NCT05533112
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2022-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of preoperative anxiety', 'timeFrame': 'Assessments will take place one day before surgery as well as before administration of the intervention', 'description': 'Binaural beat stimulation before surgery can reduce preoperative anxiety'}], 'secondaryOutcomes': [{'measure': 'Increase of EEG alpha-band power during anesthesia emergence', 'timeFrame': 'Analysis will include the last 20 minutes of surgical procedure until patients are responsive again', 'description': 'Binaural beat stimulation during anesthesia emergence can increase or stabilize EEG alpha-band power.'}, {'measure': 'Lower incidence of perioperative neurocognitive disorders', 'timeFrame': 'Incidence of perioperative neurocognitive disorders will be assessed during the patients stay in the PACU as well as one day post surgery', 'description': '2\\. Reduced preoperative anxiety and/or increased or stabilized alpha oscillations during anesthesia emergence are correlated with a lower incidence of perioperative neurocognitive disorders.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preoperative Anxiety', 'Perioperative Complication']}, 'descriptionModule': {'briefSummary': 'We plan to evaluate the potential of binaural beat stimulation as a cost-effective tool to improve perioperative patient outcome. Preoperative anxiety and postoperative neurocognitive disorders are two major issues patients have to deal with in the perioperative period. In this context, preoperative stress and anxiety are independent risk factors for postoperative neurocognitive disorders. The primary goal of our proposed study therefore is to reduce preoperative anxiety by stimulating patients with binaural beats. As binaural beats might also entrain brainwaves, the secondary goal of the study is to investigate whether binaural beats can induce alpha oscillatory activity during emergence from anesthesia. This type of oscillation has been demonstrated to be protective for postoperative neurocognitive disorders and might therefore complement the effects of preoperative anxiety reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent in German (Munich) or Portuguese (Porto)\n* Scheduled for elective minor or intermediate risk procedure\n\nExclusion Criteria:\n\n* ASA status 4\n* History of drug abuse\n* Pre-existing neurocognitive or psychiatric disorders\n* Auditory Impairments, vision diseases or other diagnosed cognitive impairments'}, 'identificationModule': {'nctId': 'NCT05533112', 'briefTitle': 'Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia', 'orgStudyIdInfo': {'id': '2022-332-S-NP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control Group, no Intervention received'}, {'type': 'EXPERIMENTAL', 'label': 'Preop Stimulation', 'description': 'Binaural Beat Stimulation preoperatively', 'interventionNames': ['Other: Binaural Beat Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Postop Stimulation', 'description': 'Binaural Beat Stimulation postoperatively', 'interventionNames': ['Other: Binaural Beat Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Pre- & Postop Stimulation', 'description': 'Binaural Beat Stimulation pre- and postoperatively', 'interventionNames': ['Other: Binaural Beat Stimulation']}], 'interventions': [{'name': 'Binaural Beat Stimulation', 'type': 'OTHER', 'description': 'During binaural beats stimulation both ears receive a tone which varies slightly in its frequency. If the left ear is stimulated with a sinusoidal wave of 98 Hz and the right ear with a sinusoidal wave of 108 Hz, the brain will perceive this stimulation as a single tone at the mean frequency of 103 Hz. The amplitude of the perceived tone will fluctuate with a frequency that is equal to the difference of the two initial tones, i.e., 10 Hz', 'armGroupLabels': ['Postop Stimulation', 'Pre- & Postop Stimulation', 'Preop Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80686', 'city': 'München', 'state': 'München (Stadt)', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Julian Ostertag, MSc', 'role': 'CONTACT', 'email': 'julian.ostertag@tum.de', 'phone': '+4941408681'}, {'name': 'Stephan Kratzer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthias Kreutzer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Technische Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'centralContacts': [{'name': 'Julian Ostertag, MSc', 'role': 'CONTACT', 'email': 'julian.ostertag@tum.de', 'phone': '+4941408681'}], 'overallOfficials': [{'name': 'Stephan Kratzer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Anästhesiologie und Intensivmedizin'}, {'name': 'Gerhard Schneider, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinik für Anästhesiologie und Intensivmedizin'}, {'name': 'Matthias Kreuzer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Anästhesiologie und Intensivmedizin'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available starting March 2023.', 'ipdSharing': 'YES', 'description': 'All recorded data may be shared with collaborating researchers', 'accessCriteria': 'Researchers who agree to collaborate on the project will have access to our protected server and can access all recorded data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}