Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
Study NCT ID:
NCT00832468
Status:
COMPLETED
Last Update Posted:
2009-12-08
First Post:
2009-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Complementary Effect of Ear Acupressure on Older Patients With Chronic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-07', 'studyFirstSubmitDate': '2009-01-29', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2009-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'polysomnography', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh sleep quality index, Heart rate variability, SF-36', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['insomnia', 'ear acupressure'], 'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'Ear acupressure is commonly applied to treat insomnia in Oriental clinical practice but lacking the evidence of the randomized controlled trial (RCT)of ear acupressure on insomnia. In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.', 'detailedDescription': 'Even though there have been many advances in the pharmacological treatment of insomnia, many patients with insomnia visit complementary and alternative medicine (CAM) specialists for help due to fear of the side effects of long-term treatment with hypnotics. Acupuncture is commonly used to treat insomnia in the field of CAM. Among the different methods of acupuncture, it has been noted that ear acupressure (placing magnetic pellets on the auricular points), which has the advantage of being non-invasive and easily carried out, shows possible effects whereby there is improvement in the sleep quality of old adults. However, it is lacking of the evidence of the randomized controlled trial (RCT) of ear acupressure on insomnia.\n\nInsomnia is related to homeostatic dysregulation of autonomic nervous system (ANS). Ear acupuncture and its related techniques are believed to act through the reticular formation and the ANS may thus result in an amelioration of illness.\n\nIn this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.Besides, the changes of ANS function (measured by heart rate variability) are recorded to evaluate the role of ANS in the treatment of insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of primary insomnia\n\nExclusion Criteria:\n\n* diabetic neuropathy\n* cardiac arrythmia\n* liver disease (ALT\\> 120 U/L)\n* renal disease (Cr\\> 2 mg/dl)\n* severe depression'}, 'identificationModule': {'nctId': 'NCT00832468', 'briefTitle': 'The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia and Anxiety', 'orgStudyIdInfo': {'id': '97032R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'sham ear acupressure', 'interventionNames': ['Other: sham ear acupressure']}, {'type': 'EXPERIMENTAL', 'label': 'ear acupressure', 'interventionNames': ['Other: ear acupressure']}], 'interventions': [{'name': 'ear acupressure', 'type': 'OTHER', 'description': 'The ear acupressure that is used involved a 0.3 cm-sized magnetic pellet on a 1 cm size sticky patch (Ching-Ming Co., Taiwan), which was placed on the bilateral ear Shenmen points; each of the points were pressed once a second for one minute (60 times) before sleep every night. The time period of the treatment course was four weeks.', 'armGroupLabels': ['ear acupressure']}, {'name': 'sham ear acupressure', 'type': 'OTHER', 'description': 'The sham ear acupressure that was used involved a 1 cm size sticky patch placed on the bilateral ear Shenmen points. There was no magnetic pellet attached to the sticker and no need to press it.', 'armGroupLabels': ['sham ear acupressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yen-ying Kung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Traditional Medicine, National Yang-Ming University and Taipei Veterans General Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yen-Ying Kung', 'oldOrganization': 'Institute of Traditional Medicine, National Yang-Ming University, Taiwan'}}}}