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Completed

NCT Number: NCT06738706

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

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

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Key information

Conditions

Cerebral Venous Outflow Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

intermittent hypoxia-hyperoxia treatment

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.

Primary outcomes

  1. Incidence of adverse reactions

    Time frame: After the 14-time IHHT interventions.

    Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.

  2. Incidence of adverse reactions

    Time frame: After the first-time IHHT intervention.

    Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.

Secondary outcomes

  1. Heart rate

    Time frame: 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.

  2. Blood pressure

    Time frame: 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.

  3. Tissue oxygen saturation

    Time frame: 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.

  4. Twenty-four-hour ambulatory blood pressure

    Time frame: The day before the 14-time treatment; The day after the 14-time treatment.

    Including systolic blood pressure and diastolic blood pressure (mmHg).

  5. Blood routine indexes

    Time frame: The day before the 14-time treatment; The day after the 14-time treatment.

    Changes in blood routine indexes will be detected.

  6. Blood biochemical changes

    Time frame: The day before the 14-time treatment; The day after the 14-time treatment.

    Changes in blood biochemical parameters will be detected.

  7. The global impression of the treatment

    Time frame: 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.

  8. Symptoms

    Time frame: The day before the 14-time treatment ;The day after the 14-time treatment.

    It is evaluated by completing the follow-up form.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Acronym: IHHT-CVOD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.