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

Not Applicable

Completed

• Conditions: Cerebral Venous Outflow Disorders

• Registration Number: NCT06738706
• Lead Sponsor: Capital Medical University

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 Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of adverse reactions	After the first-time IHHT intervention.	Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.

Secondary Outcome Measures

Name	Time	Method
Heart rate	At the first-time IHHT intervention.	Heart rate was recorded every 5 minutes from the start to 30 minutes following the completion of the first IHHT intervention.
Blood pressure	At the first-time IHHT intervention.	Brachial arterial blood pressure was measured every 5 minutes from the start to 30 minutes following the completion of the first IHHT intervention.
Tissue oxygen saturation	At the first-time IHHT intervention.	Peripheral and cerebral tissue oxygen saturations were recorded every 5 minutes from the start to 30 minutes following the completion of the first IHHT intervention.
Twenty-four-hour ambulatory blood pressure	The day before the 14-time treatment; The day after the 14-time treatment.	Including systolic blood pressure and diastolic blood pressure (mmHg).
Blood routine indexes	The day before the 14-time treatment; The day after the 14-time treatment.	Changes in blood routine indexes will be detected.
Blood biochemical changes	The day before the 14-time treatment; The day after the 14-time treatment.	Changes in blood biochemical parameters will be detected.
The global impression of the treatment	The day after the 7-day treatment.	The patient global impression of change (PGIC) scale was used after the 14 training sessions to assess the perceived global impression of change from the patient's perspective. This instrument is a numeric scale ranging from 1 (very much improved) to 7 (very much worse), with a lower score indicating better improvement.
Symptoms	The day before the 14-time treatment ;The day after the 14-time treatment.	It is evaluated by completing the follow-up form.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China