Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-03-05 @ 12:05 PM
Study NCT ID:
NCT04206059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-12-02
First Post:
2019-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-27', 'mcpReleaseN': 13, 'releaseDate': '2023-06-01'}, {'resetDate': '2025-02-10', 'mcpReleaseN': 14, 'releaseDate': '2025-01-16'}, {'resetDate': '2025-03-11', 'mcpReleaseN': 15, 'releaseDate': '2025-02-21'}], 'estimatedResultsFirstSubmitDate': '2023-06-01'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000161', 'term': 'Acoustic Stimulation'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in EEG slow wave amplitude from sham to in-phase stimulation', 'timeFrame': 'up to 3 months after consent', 'description': 'EEG slow waves amplitude relative to the timing of the stimulation'}, {'measure': 'Difference in EEG slow wave duration from sham to in-phase stimulation', 'timeFrame': 'up to 3 months after consent', 'description': 'EEG slow waves duration relative to the timing of the stimulation'}, {'measure': 'Difference in EEG slow wave amplitude from anti-phase to in-phase stimulation', 'timeFrame': 'up to 3 months after consent', 'description': 'EEG slow waves amplitude relative to the timing of the stimulation'}, {'measure': 'Difference in EEG slow wave duration from anti-phase to in-phase stimulation', 'timeFrame': 'up to 3 months after consent', 'description': 'EEG slow waves duration relative to the timing of the stimulation'}], 'secondaryOutcomes': [{'measure': 'Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation', 'timeFrame': 'up to 3 months after consent', 'description': 'Threshold for responsiveness to thermal stimulation'}, {'measure': 'Difference of reactivity to thermal stimulation from sham to in-phase stimulation', 'timeFrame': 'up to 3 months after consent', 'description': 'Threshold for responsiveness to thermal stimulation'}, {'measure': 'Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session.', 'timeFrame': 'up to 3 months after consent', 'description': 'Slow wave activity calculated during N3 sleep'}, {'measure': 'Localization of slow waves', 'timeFrame': 'up to 3 months after consent', 'description': 'Brain regions with localization of EEG slow waves during dexmedetomidine sedation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep', 'Sedation Complication']}, 'referencesModule': {'references': [{'pmid': '27927806', 'type': 'BACKGROUND', 'citation': 'Prerau MJ, Brown RE, Bianchi MT, Ellenbogen JM, Purdon PL. Sleep Neurophysiological Dynamics Through the Lens of Multitaper Spectral Analysis. Physiology (Bethesda). 2017 Jan;32(1):60-92. doi: 10.1152/physiol.00062.2015.'}, {'pmid': '29490885', 'type': 'BACKGROUND', 'citation': 'Leger D, Debellemaniere E, Rabat A, Bayon V, Benchenane K, Chennaoui M. Slow-wave sleep: From the cell to the clinic. Sleep Med Rev. 2018 Oct;41:113-132. doi: 10.1016/j.smrv.2018.01.008. Epub 2018 Feb 5.'}, {'pmid': '26834569', 'type': 'BACKGROUND', 'citation': 'Neske GT. The Slow Oscillation in Cortical and Thalamic Networks: Mechanisms and Functions. Front Neural Circuits. 2016 Jan 14;9:88. doi: 10.3389/fncir.2015.00088. eCollection 2015.'}, {'pmid': '38571816', 'type': 'DERIVED', 'citation': 'Smith SK, Kafashan M, Rios RL, Brown EN, Landsness EC, Guay CS, Palanca BJA. Daytime dexmedetomidine sedation with closed-loop acoustic stimulation alters slow wave sleep homeostasis in healthy adults. BJA Open. 2024 Mar 28;10:100276. doi: 10.1016/j.bjao.2024.100276. eCollection 2024 Jun.'}, {'pmid': '36967282', 'type': 'DERIVED', 'citation': 'Guay CS, Hight D, Gupta G, Kafashan M, Luong AH, Avidan MS, Brown EN, Palanca BJA. Breathe-squeeze: pharmacodynamics of a stimulus-free behavioural paradigm to track conscious states during sedation☆. Br J Anaesth. 2023 May;130(5):557-566. doi: 10.1016/j.bja.2023.01.021. Epub 2023 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'Prospective within-subject study of dexmedetomidine sedation paired with CLAS conditions in repeated blocks. Intervention will consist of CLAS in-phase with EEG slow waves. Anti-phase stimulation will serve as an active control while sham stimulation will serve as a passive control.', 'detailedDescription': 'Both nonpharmacologic and pharmacologic interventions augment expression of EEG slow waves that mimic those of natural sleep. Closed loop auditory stimulation (CLAS) is a noninvasive inexpensive approach to augment the spectral power and duration of these slow waves. Whether in-phase CLAS may address this need is unknown, since acoustic potentiation of pharmacologically-induced slow waves has not been investigated. This prospective within-subject study of dexmedetomidine sedation paired with CLAS will assess the feasibility of augmenting EEG slow waves during sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40 years\n* Healthy volunteers (American Society of Anesthesiologists Physical Status 1-2).\n\nExclusion Criteria:\n\n* Diagnosed sleep disorders\n* Habitually short sleepers\n* Diagnosed psychiatric disorders\n* Use of psychoactive medication (e.g., antidepressants, mood stabilizers or antipsychotics), diagnosed hearing disorder\n* Neck circumference \\> 40 cm\n* Body Mass Index \\> 30\n* Acknowledged recreational drug or nicotine use\n* Resting heart rate during slow wave sleep \\< 40 beats per minute\n* Pregnancy or nursing\n* Persistently inconsistent or elevated QST heat pain tolerance thresholds (\\>50 ºC).'}, 'identificationModule': {'nctId': 'NCT04206059', 'acronym': 'CLASS-D', 'briefTitle': 'Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine', 'orgStudyIdInfo': {'id': '201907086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLASS-D Cohort', 'description': 'Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.', 'interventionNames': ['Radiation: MRI', 'Diagnostic Test: Quantitative Sensory Testing (QST)', 'Diagnostic Test: Home sleep study', 'Other: Acoustic stimulation (65db) up-slope of EEG with QST', 'Other: Acoustic stimulation (65db) down-slope of EEG with QST', 'Other: 0 db with QST', 'Drug: Dexmedetomidine', 'Other: Breathe-Squeeze Task']}], 'interventions': [{'name': 'MRI', 'type': 'RADIATION', 'otherNames': ['Structural magnetic resonance imaging'], 'description': 'A non-contrast brain MRI will be acquired for localizing EEG slow waves', 'armGroupLabels': ['CLASS-D Cohort']}, {'name': 'Quantitative Sensory Testing (QST)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Quantitative Sensory Testing'], 'description': 'Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.', 'armGroupLabels': ['CLASS-D Cohort']}, {'name': 'Home sleep study', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Unattended polysomnography'], 'description': 'Unattended home sleep studies will be conducted on the night preceding sedation and on the night following sedation to assess changes in slow wave homeostasis.', 'armGroupLabels': ['CLASS-D Cohort']}, {'name': 'Acoustic stimulation (65db) up-slope of EEG with QST', 'type': 'OTHER', 'otherNames': ['In-phase CLAS with sensory testing'], 'description': 'Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves', 'armGroupLabels': ['CLASS-D Cohort']}, {'name': 'Acoustic stimulation (65db) down-slope of EEG with QST', 'type': 'OTHER', 'otherNames': ['Anti-phase CLAS with sensory testing'], 'description': '65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)', 'armGroupLabels': ['CLASS-D Cohort']}, {'name': '0 db with QST', 'type': 'OTHER', 'otherNames': ['Sham CLAS with sensory testing'], 'description': 'sham stimulation (0 dB volume)', 'armGroupLabels': ['CLASS-D Cohort']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine hydrochloride'], 'description': 'All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml', 'armGroupLabels': ['CLASS-D Cohort']}, {'name': 'Breathe-Squeeze Task', 'type': 'OTHER', 'otherNames': ['Internally directed behavioral task'], 'description': 'All participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.', 'armGroupLabels': ['CLASS-D Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine/Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Ben J Palanca, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ben J.A. Palanca', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}