Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT05248360
Status:
UNKNOWN
Last Update Posted:
2022-12-15
First Post:
2022-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrogen-oxygen Mixed Gas in the Treatment of 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in sleep efficiency by polysomnography (PSG) at 10 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 6(10th week)', 'description': "This outcome reflects change of patients' sleep quality."}, {'measure': 'Change from baseline in total sleep time by PSG at 10 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 6(10th week)', 'description': "This outcome reflects change of patients' sleep quality."}, {'measure': 'Change from baseline in sleep latency by PSG at 10 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 6(10th week)', 'description': "This outcome reflects change of patients' sleep quality."}, {'measure': 'Change from baseline in wake time after sleep onset by PSG at 10 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 6(10th week)', 'description': "This outcome reflects change of patients' sleep quality."}, {'measure': 'Change from baseline in Insomnia Severity Index (ISI) score at 14 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)', 'description': 'The ISI is widely used to measure the severity of Insomnia. The ISI score ranges from 0 to 28. The higher the ISI score is, the worse the symptoms are.'}, {'measure': 'Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score at 14 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)', 'description': 'The PSQI is widely used to measure sleep quality. The PSQI score ranges from 0 to 21. The higher the PSQI score is, the worse the sleep quality is.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Hamilton Anxiety Scale (HAMA) score at 14 weeks', 'timeFrame': 'Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)', 'description': 'The HAMA is a widely used interview scale to measure the severity of anxiety. The HAMA score ranges from 0 to 56. The higher the HAMA score is, the worse the symptoms are.'}, {'measure': 'Change from baseline in Hamilton Depression Scale-17 (HAMD-17) score at 14 weeks', 'timeFrame': 'Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)', 'description': 'The HAMD-17 is a test measuring the severity of depressive symptoms. The HAMA-17 score ranges from 0 to 52. The higher the HAMA score is, the worse the symptoms are.'}, {'measure': 'Change from baseline in Mini-Mental State Examination (MMSE) score at 14 weeks', 'timeFrame': 'Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)', 'description': 'The MMSE is widely used to assess cognition. The MMSE score ranges from 0 to 30. The higher the HAMA score is, the better the cognitive function is.'}, {'measure': 'Change from baseline in Montreal Cognitive Assessment (MOCA) score at 14 weeks', 'timeFrame': 'Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)', 'description': 'The MoCA is widely used to assess cognition. The HAMA-17 score ranges from 0 to 30. The higher the HAMA score is, the better the cognitive function is.'}, {'measure': 'Change from baseline in C-reactive protein (CRP) at 10 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 6(10th week)', 'description': "This outcome reflects change of patients' serum inflammatory factor."}, {'measure': 'Change from baseline in Interleukin-6 (IL-6) at 10 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 6(10th week)', 'description': "This outcome reflects change of patients' serum inflammatory factor."}, {'measure': 'Change from baseline in Interleukin-1β ( IL-1β) at 10 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 6(10th week)', 'description': "This outcome reflects change of patients' serum inflammatory factor."}, {'measure': 'Change from baseline in tumor necrosis factor-α (TNF-α) at 10 weeks', 'timeFrame': 'visit 1(baseline), visit 3(4th week), visit 6(10th week)', 'description': "This outcome reflects change of patients' serum inflammatory factor."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Hydrogen-oxygen Mixed Gas'], 'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '26140821', 'type': 'BACKGROUND', 'citation': 'Irwin MR, Olmstead R, Carroll JE. Sleep Disturbance, Sleep Duration, and Inflammation: A Systematic Review and Meta-Analysis of Cohort Studies and Experimental Sleep Deprivation. Biol Psychiatry. 2016 Jul 1;80(1):40-52. doi: 10.1016/j.biopsych.2015.05.014. Epub 2015 Jun 1.'}, {'pmid': '25747486', 'type': 'BACKGROUND', 'citation': 'Ohta S. Molecular hydrogen as a novel antioxidant: overview of the advantages of hydrogen for medical applications. Methods Enzymol. 2015;555:289-317. doi: 10.1016/bs.mie.2014.11.038. Epub 2015 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas inhalation in the treatment of insomnia.', 'detailedDescription': 'This ia a randomized, double-blind, crossover, placebo-controlled Study. The purpose is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas(H2-O2) inhalation in the treatment of insomnia, and explore the possible mechanism by detecting the changes of serum inflammatory factors (CRP, IL-6, IL-1β, TNF-α) levels, so as to seek an effective therapy for insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).\n2. No use of sleep medications within the preceding 2 weeks, or a stable dose of only one sedative hypnotic medicine for at least 1 month before the enrollment and remain unchanged throughout the course of the study.\n3. Signed informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Complicated with other sleep disorders (sleep apnea syndrome, narcolepsy, restless legs syndrome, nocturia, etc.);\n2. Complicated with serious heart, lung, liver or renal diseases or malignant tumor;\n3. History of mental illness;\n4. Drugs or substances abuse;\n5. Pregnant women, breast-feeding women or those with recent birth plans;\n6. Participants in other clinical trials within 1 month before the study.'}, 'identificationModule': {'nctId': 'NCT05248360', 'briefTitle': 'Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Soochow University'}, 'officialTitle': 'A Randomized, Double-blind, Crossover, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia', 'orgStudyIdInfo': {'id': 'JD-LK-2021-100-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Hydrogen-oxygen mixed gas(H2-O2, 66.6% hydrogen, 33.3% oxygen) inhalation, 900ml/min, 2h/d', 'interventionNames': ['Device: Hydrogen-oxygen mixed gas(H2-O2) inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Air inhalation, 900ml/min, 2h/d', 'interventionNames': ['Device: Air inhalation']}], 'interventions': [{'name': 'Hydrogen-oxygen mixed gas(H2-O2) inhalation', 'type': 'DEVICE', 'description': 'H2-O2 inhalation, 900ml/min, 2h/d \\* 4 weeks (≥5 days/week)', 'armGroupLabels': ['Experimental group']}, {'name': 'Air inhalation', 'type': 'DEVICE', 'description': 'Air inhalation, 900ml/min, 2h/d \\* 4 weeks (≥5 days/week)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215004', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of Neurology, Second Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'overallOfficials': [{'name': 'Chun-Feng Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chun-Feng Liu', 'investigatorAffiliation': 'Second Affiliated Hospital of Soochow University'}}}}