Intermittent Hypoxia-Hyperoxia Training in Cerebral Venous Outflow Disorders (IHHT-CVOD)

Capital Medical University

Status: Completed

Conditions: Cerebral Venous Outflow Disorders

Treatments: Device: intermittent hypoxia-hyperoxia treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06738706

IHHT-CVOD

Details and patient eligibility

About

This study aims to investigate the safety and efficacy of intermittent hypoxia-hyperoxia treatment in patients with cerebral venous outflow disorders.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age range from 18 to 80 years.
2. 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.
3. Unexplained chronic neurological deficits or other symptoms > 3 months.
4. Signed informed consent from the patient or legally authorized representative.

Exclusion criteria

1. Life-threatening comorbidities.
2. Clinical symptoms and signs explained by other diseases.
3. Intracranial hypertension; moderate to severe intracranial/extracranial arterial stenosis.
4. History of ischemic/hemorrhagic stroke or cerebral endovascular surgery.
5. Intracranial abnormalities, such as tumors, abscesses, vascular malformations, or cerebral venous sinus thrombosis.
6. Confirmed sleep apnea, plateau residency, traveling history of altitude > 1000m, or relative hypoxic exposure within last six months.
7. Poor compliance.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intermittent Hypoxia-Hyperoxia Training

Experimental group

Description:

Participants will receive 14 times intermittent hypoxia-hyperoxia training interventions within 2 to 3 weeks.

Treatment:

Device: intermittent hypoxia-hyperoxia treatment