Exploratory Study of the Impact of Intermittent Hypoxia-hyperoxia Training on Patients with Cerebral Venous Outflow Disorders
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Capital Medical University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of adverse reactions
Overview
Brief Summary
This study aims to investigate the safety and efficacy of intermittent hypoxia-hyperoxia treatment in patients with cerebral venous outflow disorders.
Detailed Description
Cerebral venous outflow disorder (CVOD), resulting from internal blockage, external oppression, or jugular valve incompetence, can cause hemodynamic disturbance and abnormal perfusion status. Restricted applicable populations and limited benefits constrain the application of existing CVOD management approaches. Previous studies indicate intermittent hypoxia hyperoxia training (IHHT) might improve circulatory status via hypoxic stimulation and allow hypoxic-related symptom amelioration through oxygen supply. Thus, IHHT might be a promising therapy for the CVOD population. Studies have so far proved inconclusive as to whether IHHT is safe and effective for CVOD. Therefore, the present study aimed to investigate the safety and feasibility of IHHT in patients with cerebral venous outflow disorder.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age range from 18 to 80 years.
- •Diagnosis of CVOD confirmed by CE-MRV, DSA, CTV, or ultrasound, including cerebral venous sinus stenosis (CVSS), internal jugular venous stenosis (IJVS), or internal jugular venous valve incompetence.
- •Unexplained chronic neurological deficits or other symptoms \> 3 months.
- •Signed informed consent from the patient or legally authorized representative.
Exclusion Criteria
- •Life-threatening comorbidities.
- •Clinical symptoms and signs explained by other diseases.
- •Intracranial hypertension; moderate to severe intracranial/extracranial arterial stenosis.
- •History of ischemic/hemorrhagic stroke or cerebral endovascular surgery.
- •Intracranial abnormalities, such as tumors, abscesses, vascular malformations, or cerebral venous sinus thrombosis.
- •Confirmed sleep apnea, plateau residency, traveling history of altitude \> 1000m, or relative hypoxic exposure within last six months.
- •Poor compliance.
Outcomes
Primary Outcomes
Incidence of adverse reactions
Time Frame: After the first-time IHHT intervention.
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.
Secondary Outcomes
- Heart rate(At the first-time IHHT intervention.)
- Blood pressure(At the first-time IHHT intervention.)
- Tissue oxygen saturation(At the first-time IHHT intervention.)
- Twenty-four-hour ambulatory blood pressure(The day before the 14-time treatment; The day after the 14-time treatment.)
- Blood routine indexes(The day before the 14-time treatment; The day after the 14-time treatment.)
- Blood biochemical changes(The day before the 14-time treatment; The day after the 14-time treatment.)
- The global impression of the treatment(The day after the 7-day treatment.)
- Symptoms(The day before the 14-time treatment ;The day after the 14-time treatment.)
Investigators
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University