Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04838067
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2021-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Therapeutic Effects of Cefaly on Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-03', 'size': 54948, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-04T23:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2021-04-04', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh sleep quality index(PSQI)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Pittsburgh sleep quality index scores PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance.'}, {'measure': 'Insomnia severity index(ISI)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Insomnia severity index scores ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity.'}, {'measure': 'Epworth sleepiness scale(ESS)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Epworth sleepiness scale scores Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.'}, {'measure': 'Polysomnography measures-1 (Total sleep time)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Total sleep time'}, {'measure': 'Polysomnography measures-2 (Wake after sleep onset)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Wake after sleep onset'}, {'measure': 'Polysomnography measures-3( Stage 1 sleep period)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Stage 1 sleep period'}, {'measure': 'Polysomnography measures-4(Stage 2 sleep period)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Stage 2 sleep period'}, {'measure': 'Polysomnography measures-5(Stage 3 sleep period)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Stage 3 sleep period'}, {'measure': 'Polysomnography measures-6(Total rapid eye movement sleep period)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Total rapid eye movement sleep period'}, {'measure': 'Polysomnography measures-7(Rapid eye movement sleep latency)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Rapid eye movement sleep latency'}, {'measure': 'Polysomnography measures-8(Sleep latency)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Sleep latency'}, {'measure': 'Polysomnography measures-9(Apnea hypopnea index)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Apnea hypopnea index'}, {'measure': 'Neuroimaging parameter changes-1(Resting state network functional connectivity)', 'timeFrame': '4 weeks after intervention', 'description': 'Resting state network functional connectivity changes'}, {'measure': 'Neuroimaging parameter changes-2(Cortical thickness)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Cortical thickness'}, {'measure': 'Neuroimaging parameter changes-4(Fractional anisotropy)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Fractional anisotropy'}, {'measure': 'Neuroimaging parameter changes-5(Mean diffusivity)', 'timeFrame': '4 weeks after intervention', 'description': 'Changes in Mean diffusivity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Initiation and Maintenance Disorders']}, 'referencesModule': {'references': [{'pmid': '35619611', 'type': 'DERIVED', 'citation': 'Um YH, Wang SM, Kang DW, Kim NY, Lim HK. Alterations of Resting-State Locus Coeruleus Functional Connectivity After Transdermal Trigeminal Electrical Neuromodulation in Insomnia. Front Psychiatry. 2022 May 10;13:875227. doi: 10.3389/fpsyt.2022.875227. eCollection 2022.'}, {'pmid': '34383274', 'type': 'DERIVED', 'citation': 'Um YH, Wang SM, Kang DW, Kim NY, Lim HK. Impact of transdermal trigeminal electrical neuromodulation on subjective and objective sleep parameters in patients with insomnia: a pilot study. Sleep Breath. 2022 Jun;26(2):865-870. doi: 10.1007/s11325-021-02459-0. Epub 2021 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to examine whether the Cefaly has a therapeutic effect on insomnia patients visiting a psychiatric clinic in Korea. The study design is a single site, single-armed exploratory study. Insomnia patients received a 20-minute daily sessions of the Cefaly for 4 weeks. Primary endpoint was a reduction of scores in Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, improvements in polysomnography measures, and changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity', 'detailedDescription': 'Insomnia is well-known for its association with adverse health outcomes. Although insomnia is usually treated with hypnotics or cognitive behavioral therapy for insomnia, the need for novel nonpharmacological treatment for insomnia is increasing emphasized due to reports of side effects and detrimental consequences of hypnotics. Trigeminal nerve electrical neuromodulation has been suggested as a potential treatment modality through its modulation of noradrenergic activity that results in promoting relaxation and reducing hyperarousal. Insomnia patients enrolled in the study will go through a 20-minute daily session of the Cefaly device(originally FDA-approved device for migraine, which electrically modulates trigeminal nerve) for 4 weeks. The objective of this study is to test whether trigeminal nerve electrical neuromodulation has a therapeutic effect, validation measures involving subjective measures(Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale), objective measures(Polysomnography measures) and neuroimaging(changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have adequately understood the whole study procedures within age range of 19-64 years\n2. Patients with insomnia severity index (ISI) score of more than 15\n\nExclusion Criteria:\n\n1. Cognitive impairment\n2. Psychiatric disorders or neurological disorders.\n3. Unstable medical conditions\n4. Prior diagnosis of sleep disorders\n5. Hypnotic prescription\n6. History of brain or facial trauma within 3 months\n7. Skin abrasions\n8. Acrylic acid allergy\n9. Electromagnetic hypersensitivity\n10. Apnea hypopnea index of \\>15/hour in the baseline polysomnography.'}, 'identificationModule': {'nctId': 'NCT04838067', 'briefTitle': 'Validation of Therapeutic Effects of Cefaly on Insomnia', 'organization': {'class': 'OTHER', 'fullName': "Saint Vincent's Hospital, Korea"}, 'officialTitle': 'Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study', 'orgStudyIdInfo': {'id': 'VC18DNSI0145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefaly Intervention', 'description': 'Cefaly', 'interventionNames': ['Device: Cefaly']}], 'interventions': [{'name': 'Cefaly', 'type': 'DEVICE', 'description': 'Transcutaneous trigeminal nerve electrical neuromodulation', 'armGroupLabels': ['Cefaly Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'country': 'South Korea', 'facility': "St.Vincent's Hospital, the Catholic University of Korea", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Se-Min Choung', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CMC IRB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint Vincent's Hospital, Korea", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Yoo Hyun Um', 'investigatorAffiliation': "Saint Vincent's Hospital, Korea"}}}}