Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-02 @ 10:43 AM
Study NCT ID:
NCT05152095
Status:
UNKNOWN
Last Update Posted:
2021-12-30
First Post:
2021-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-13', 'releaseDate': '2023-03-10'}], 'estimatedResultsFirstSubmitDate': '2023-03-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001008', 'term': 'Anxiety 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-10', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-05', 'lastUpdatePostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': '6th day', 'description': 'Total score categories:\n\n0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': '11th day', 'description': 'Total score categories:\n\n0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)'}, {'measure': 'Hamilton Anxiety Rating Scale (HAM-A)', 'timeFrame': '6th day', 'description': 'Total score range of 0-56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.'}, {'measure': 'Hamilton Anxiety Rating Scale (HAM-A)', 'timeFrame': '11th day', 'description': 'Total score range of 0-56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['auricular acupressure', 'insomnia', 'anxiety', 'randomized sham controlled trial'], 'conditions': ['Insomnia Due to Anxiety and Fear']}, 'descriptionModule': {'briefSummary': 'This is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in Malaysia.', 'detailedDescription': '112 subjects with insomnia and anxiety who fit to the inclusion and exclusion criteria will be recruited into the trial. After initial screening, subjects will be randomly allocated to Vaccaria seed tapes (experimental arm) or non-Varracia seed plain tapes (sham comparator arm).\n\nOn the sixth day for the trial (after 5 days of daily auricular acupressure), the ISI and HAM-A score of subjects will be reassessed again. The subjects have to stop applying auricular acupressure for the next five days and reassess their ISI and HAM-A score again on the eleventh day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Malaysian aged above 18 years old who are suffering from chronic insomnia based on International Classification of Sleep Disorders 3(ICSD-3) and with Insomnia Severity Index (ISI) of 18 and above and more than 3 months.\n* Willing to comply with the recommended periodic acupressure stimulation every day during the 1 week period.\n\nExclusion Criteria:\n\n* Subject with insomnia score below 18 based on Insomnia Severity Index (ISI).\n* Subject with stress and anxiety level below 18 in the Hamilton Anxiety Rating Scale (HAM-A).\n* Subject with the history of skin sensitivity.\n* Subject who just started on new medication to treat insomnia.'}, 'identificationModule': {'nctId': 'NCT05152095', 'briefTitle': 'Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'IMU University, Malaysia'}, 'officialTitle': 'Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial', 'orgStudyIdInfo': {'id': 'BCM I-2021 (04)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Self-administered Vaccaria seed tapes on auricular acupoints with pressure applied', 'interventionNames': ['Other: Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Self-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure.', 'interventionNames': ['Other: Plain ear adhesive tape']}], 'interventions': [{'name': 'Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure', 'type': 'OTHER', 'description': 'Apply on auricular acupoints, Shenmen and Occiput, apply pressure for 3 minutes, 5 times per day, at the interval of 2 \\~ 3 hours, for 5 days.', 'armGroupLabels': ['Intervention']}, {'name': 'Plain ear adhesive tape', 'type': 'OTHER', 'description': 'Apply on Shenmen and Occiput without applying pressure for 5 days.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Ms Tang', 'role': 'CONTACT', 'phone': '03-27317202'}], 'facility': 'International Medical University (IMU)', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Ms Tang', 'role': 'CONTACT', 'email': 'freyatang@imu.edu.my', 'phone': '03-27317202'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IMU University, Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Tang Sin Wei', 'investigatorAffiliation': 'IMU University, Malaysia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-03-10', 'type': 'RELEASE'}, {'date': '2023-12-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tang Sin Wei, Lecturer, IMU University, Malaysia'}}}}