Cerebral Venous Outflow DisordersIHHT-CVODNCT06738706
Intermittent Hypoxia-Hyperoxia Training in Cerebral Venous Outflow Disorders (IHHT-CVOD)
A study testing intermittent hypoxia-hyperoxia treatment in people with Cerebral Venous Outflow Disorders, run by Capital Medical University at 1 site in China.
Trial summary
This study aims to investigate the safety and efficacy of intermittent hypoxia-hyperoxia treatment in patients with cerebral venous outflow disorders. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Venous Outflow Disorders
- What is being tested?
- intermittent hypoxia-hyperoxia treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Venous Outflow Disorders
- Being tested
- intermittent hypoxia-hyperoxia treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent hypoxia-hyperoxia treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Hypoxia-Hyperoxia Training | Experimental | Participants will receive 14 times intermittent hypoxia-hyperoxia training interventions within 2 to 3 weeks. Receives: Device: intermittent hypoxia-hyperoxia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.
Measured: After the 14-time IHHT interventions.
Incidence of adverse reactions
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.
Measured: After the first-time IHHT intervention.
Secondary outcomes (8)
Heart rate
Heart rate was recorded every 5 minutes from the start to 30 minutes following the completion of the first IHHT intervention.
Measured: 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.
Measured: 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.
Measured: At the first-time IHHT intervention.
Twenty-four-hour ambulatory blood pressure
Including systolic blood pressure and diastolic blood pressure (mmHg).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The day after the 7-day treatment.
Symptoms
It is evaluated by completing the follow-up form.
Measured: The day before the 14-time treatment ;The day after the 14-time treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Dec 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous Outflow DisordersStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738706
- Sponsor's protocol ID
- IHHT-CVOD
- Acronym
- IHHT-CVOD
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Impact of Intermittent Hypoxia-hyperoxia Training on Patients with Cerebral Venous Outflow Disorders
- ClinicalTrials.gov ID
- NCT06738706
- Acronym / sponsor ID
- IHHT-CVOD / IHHT-CVOD
- Conditions
- Cerebral Venous Outflow Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent Hypoxia-Hyperoxia Training | Experimental | Device: intermittent hypoxia-hyperoxia treatmentParticipants will receive 14 times intermittent hypoxia-hyperoxia training interventions within 2 to 3 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent hypoxia-hyperoxia treatmentThe 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. | Device | Intermittent Hypoxia-Hyperoxia Training |
Primary outcome
Incidence of adverse reactions
Time frame: After the 14-time IHHT interventions.
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.
Incidence of adverse reactions
Time frame: After the first-time IHHT intervention.
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.
8 secondary outcomes
Heart rate
Time frame: At the first-time IHHT intervention.
Blood pressure
Time frame: At the first-time IHHT intervention.
Tissue oxygen saturation
Time frame: At the first-time IHHT intervention.
Twenty-four-hour ambulatory blood pressure
Time frame: The day before the 14-time treatment; The day after the 14-time treatment.
Blood routine indexes
Time frame: The day before the 14-time treatment; The day after the 14-time treatment.
Blood biochemical changes
Time frame: The day before the 14-time treatment; The day after the 14-time treatment.
The global impression of the treatment
Time frame: The day after the 7-day treatment.
Symptoms
Time frame: The day before the 14-time treatment ;The day after the 14-time treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent hypoxia-hyperoxia treatment in people with Cerebral Venous Outflow Disorders, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: After the 14-time IHHT interventions.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.