Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-13 @ 12:29 PM
Study NCT ID:
NCT02242708
Status:
UNKNOWN
Last Update Posted:
2014-09-17
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-15', 'studyFirstSubmitDate': '2014-09-15', 'studyFirstSubmitQcDate': '2014-09-15', 'lastUpdatePostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve sleep quality.', 'timeFrame': 'Change from baseline in sleep quality at 3 months.', 'description': 'Sleep quality will be assessed by pittsburg sleep quality index at three different times: (1)baseline data: before alternate nostril breathing practice ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.'}], 'secondaryOutcomes': [{'measure': 'Enhance human immunity', 'timeFrame': 'Change from baseline in human immunity at 3 months.', 'description': 'Lymphocytes will be extracted from peripheral blood for analyses of lymphocytes subpopulation, polarization and its related cytokines. Saliva will be collected at 3 different times: (1)baseline data: before alternate nostril breathing program ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.'}, {'measure': 'Improve autonomic nervous function', 'timeFrame': 'Change from baseline in autonomic nervous function at 3 months.', 'description': 'Autonomic nervous function will be assessed by biofeedback index using heart rate variability at three different times: (1)baseline data: before alternate nostril breathing practice ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Shift Nurses']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative nostril breathing to improve life quality, autonomic nervous system and immune status.', 'detailedDescription': 'Breathing is regulated by autonomic nervous system. It is well-known that breathing exercise can regulate autonomic nervous function and promote relaxation. However, the mechanism for better immunity and sleep quality is not clear. We postulate that alternative nostril breathing might benefit nurses after undergoing shift work. The benefits could be due to improvement of autonomic nervous function, sleep quality, and even immune function.\n\nThe study design will include a randomization of two groups, with a control group and one experimental groups for 3 months (12 weeks). The control group will do normal breathing. The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.\n\nThe study primary endpoints are 1) to improve autonomic nervous function, 2) to improve sleep quality and 3) to enhance human immunity.\n\nWe anticipate to reach the primary endpoints and publish the primary results in one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Shift nurses\n\nExclusion Criteria:\n\n* Upper respiratory tract infection such as nasal congestion, runny nose, coughing, wheezing, nosebleeds, fever and other symptoms.'}, 'identificationModule': {'nctId': 'NCT02242708', 'briefTitle': 'The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing', 'organization': {'class': 'OTHER', 'fullName': 'Chang Bing Show Chwan Memorial Hospital'}, 'officialTitle': 'The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing', 'orgStudyIdInfo': {'id': '1010807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Normal breathing', 'description': 'The control group will do normal breathing.'}, {'type': 'EXPERIMENTAL', 'label': 'Alternative nostril breathing', 'description': 'The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.', 'interventionNames': ['Behavioral: Alternative nostril breathing']}], 'interventions': [{'name': 'Alternative nostril breathing', 'type': 'BEHAVIORAL', 'description': 'The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.', 'armGroupLabels': ['Alternative nostril breathing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua County', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuender D. Yang, PhD', 'role': 'CONTACT', 'email': 'yangkd.yeh@hotmail.com', 'phone': '886-975617006'}], 'facility': 'Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital'}], 'centralContacts': [{'name': 'Kuender D. Yang, PhD', 'role': 'CONTACT', 'email': 'yehshuhui@gmail.com', 'phone': '886-975617006'}], 'overallOfficials': [{'name': 'Kuender D. Yang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chang Bing Show Chwan Memorial Hospital'}, {'name': 'Ming-Ho Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Bing Show Chwan Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Bing Show Chwan Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.', 'investigatorFullName': 'Ming-Ho Lee', 'investigatorAffiliation': 'Chang Bing Show Chwan Memorial Hospital'}}}}