Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 3:15 AM
Study NCT ID:
NCT05824104
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2023-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse reactions', 'timeFrame': 'After the 7-day treatment.', 'description': 'Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.'}, {'measure': 'Incidence of adverse reactions', 'timeFrame': 'Thirty days after the treatment.', 'description': 'Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.'}], 'secondaryOutcomes': [{'measure': 'Tissue oxygen saturation', 'timeFrame': 'Baseline, after the 7-day treatment, 30 days after the treatment.', 'description': 'Including peripheral oxygen saturation and brain tissue oxygen saturation (%).'}, {'measure': 'Cerebral blood flow', 'timeFrame': 'Baseline, after the 7-day treatment.', 'description': 'Cerebral blood flow will be detected by transcranial color-coded duplex sonography.'}, {'measure': 'Neurobehavioral scale 1', 'timeFrame': 'Baseline, after the 7-day treatment.', 'description': 'It is evaluated by scales of Mini-mental State Examination (MMSE), which ranges from 0-30 points, and higher scores mean a worse outcome.'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline, after the 7-day treatment, 30 days after the treatment.', 'description': 'Including systolic blood pressure and diastolic blood pressure (mmHg).'}, {'measure': 'Neurobehavioral scale 2', 'timeFrame': 'Baseline, after the 7-day treatment.', 'description': 'It is evaluated by scales of Montreal Cognitive Assessment (MoCA), which ranges from 0-30 points, and higher scores mean a worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Cerebral Hypoperfusion']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.', 'detailedDescription': 'Chronic cerebral hypoperfusion is a common and frequently occurring disease in middle-aged and senior people, and an important cause of multiple diseases such as acute ischemic stroke and vascular dementia. However, current treatments for chronic cerebral hypoperfusion are limited and nonspecific. Intermittent hypoxia refers to periodic intervention with alternating normoxia and hypoxia. Studies have shown that short-term (5-10min), low frequency (3-15 times), and mild to moderate hypoxia (9-16%) usually have protective effects and can improve cerebral blood perfusion. Therefore, this study is an exploratory study combining intermittent hypoxia treatment with chronic cerebral hypoperfusion, aiming to preliminarily explore the safety and potential effectiveness of intermittent hypoxia treatment in the using of chronic cerebral hypoperfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 45-70 years, BMI 18.5-24kg/m2, both sexes.\n* Subjects with risk factors of cerebrovascular disease, such as hypertension, diabetes, dyslipidemia, and so on, and the risk factors are well controlled.\n* Cerebral/carotid ultrasound showed mild stenosis of unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) (\\<50%) without stenosis of other major feeding arteries.\n* Subjects with the manifestations of chronic cerebral hypoperfusion, such as dizziness, head pain, memory loss, slow reaction, inattention, emotional instability, decreased ability to work, sleep disorders and mood disorders, the course of more than 3 months.\n* Subjects or their legally authorized representative can provide informed consent.\n\nExclusion Criteria:\n\n* Stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination.\n* Uncontrolled hypertension (systolic blood pressure ≥200mmHg) with antihypertensive drugs before enrollment, other cardiovascular diseases.\n* History of pulmonary, hepatic, dermatologic, or hematologic diseases.\n* History of substance abuse.\n* Pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.'}, 'identificationModule': {'nctId': 'NCT05824104', 'briefTitle': 'Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion', 'orgStudyIdInfo': {'id': 'IH-CCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'The intermittent hypoxia protocol refers to four cycles of 5 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days.', 'interventionNames': ['Other: Intermittent Hypoxia']}], 'interventions': [{'name': 'Intermittent Hypoxia', 'type': 'OTHER', 'description': 'The intermittent hypoxia protocol refers to four cycles of 5 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yuan Wang, M.D.', 'role': 'CONTACT', 'email': 'wilma0106@163.com', 'phone': '+86-135 8156 7815'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}