Clinical trial NCT06738706: Intermittent Hypoxia-Hyperoxia Training in Cerebral Venous Outflow Disorders (IHHT-CVOD)
Official title: Exploratory Study of the Impact of Intermittent Hypoxia-hyperoxia Training on Patients with Cerebral Venous Outflow Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Venous Outflow Disorders
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse reactions
timeFrame: After the 14-time IHHT interventions.
measure: Incidence of adverse reactions
timeFrame: After the first-time IHHT intervention.
Secondary outcomes:
measure: Heart rate
timeFrame: At the first-time IHHT intervention.
measure: Blood pressure
timeFrame: At the first-time IHHT intervention.
measure: Tissue oxygen saturation
timeFrame: At the first-time IHHT intervention.
measure: Twenty-four-hour ambulatory blood pressure
timeFrame: The day before the 14-time treatment; The day after the 14-time treatment.
measure: Blood routine indexes
timeFrame: The day before the 14-time treatment; The day after the 14-time treatment.
measure: Blood biochemical changes
timeFrame: The day before the 14-time treatment; The day after the 14-time treatment.
measure: The global impression of the treatment
timeFrame: The day after the 7-day treatment.
measure: Symptoms
timeFrame: The day before the 14-time treatment ;The day after the 14-time treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: