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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Hypoxia-Hyperoxia Training | Experimental | Participants will receive 14 times intermittent hypoxia-hyperoxia training interventions within 2 to 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| 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. |