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

NCT ID: NCT06738706

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Cerebral Venous Outflow Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intermittent Hypoxia-Hyperoxia Training

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

Group Type EXPERIMENTAL

intermittent hypoxia-hyperoxia treatment

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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IHHT-CVOD

Identifier Type: -

Identifier Source: org_study_id