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

Exploratory Study of the Impact of Intermittent Hypoxia-hyperoxia Training on Patients with Cerebral Venous Outflow Disorders

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

Study Overview

• Status: Completed
• Conditions: Cerebral Venous Outflow Disorders
• Intervention / Treatment: Device: intermittent hypoxia-hyperoxia treatment

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent Hypoxia-Hyperoxia Training; Participants will receive 14 times intermittent hypoxia-hyperoxia training interventions within 2 to 3 weeks.	Device: intermittent hypoxia-hyperoxia treatment; The intermittent hypoxia-hyperoxia training refers to 4 cycles of 10-minute hypoxia inhalation interspersed with 20-minute hyperoxia, which is performed once daily for 14 days within 2 to 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.	After the 14-time IHHT interventions.
Incidence of adverse reactions	Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.	After the first-time IHHT intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate was recorded every 5 minutes from the start to 30 minutes following the completion of the first IHHT intervention.	At the first-time IHHT intervention.
Blood pressure	Brachial arterial blood pressure was measured every 5 minutes from the start to 30 minutes following the completion of the first IHHT intervention.	At the first-time IHHT intervention.
Tissue oxygen saturation	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.	At the first-time IHHT intervention.
Twenty-four-hour ambulatory blood pressure	Including systolic blood pressure and diastolic blood pressure (mmHg).	The day before the 14-time treatment; The day after the 14-time treatment.
Blood routine indexes	Changes in blood routine indexes will be detected.	The day before the 14-time treatment; The day after the 14-time treatment.
Blood biochemical changes	Changes in blood biochemical parameters will be detected.	The day before the 14-time treatment; The day after the 14-time treatment.
The global impression of the 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.	The day after the 7-day treatment.
Symptoms	It is evaluated by completing the follow-up form.	The day before the 14-time treatment ;The day after the 14-time treatment.

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Hyperoxia
• Other Study ID Numbers: IHHT-CVOD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No