Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion

This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Cerebral Hypoperfusion
• Intervention / Treatment: Other: Intermittent Hypoxia

Detailed Description

Chronic cerebral hypoperfusion is a common and frequently occurring disease in middle-aged and senior people, and an important cause of multiple diseases such as acute ischemic stroke and vascular dementia. However, current treatments for chronic cerebral hypoperfusion are limited and nonspecific. Intermittent hypoxia refers to periodic intervention with alternating normoxia and hypoxia. Studies have shown that short-term (5-10min), low frequency (3-15 times), and mild to moderate hypoxia (9-16%) usually have protective effects and can improve cerebral blood perfusion. Therefore, this study is an exploratory study combining intermittent hypoxia treatment with chronic cerebral hypoperfusion, aiming to preliminarily explore the safety and potential effectiveness of intermittent hypoxia treatment in the using of chronic cerebral hypoperfusion.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Wang, M.D.; Phone Number: +86-135 8156 7815; Email: wilma0106@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subjects aged 45-70 years, BMI 18.5-24kg/m2, both sexes.
• Subjects with risk factors of cerebrovascular disease, such as hypertension, diabetes, dyslipidemia, and so on, and the risk factors are well controlled.
• Cerebral/carotid ultrasound showed mild stenosis of unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) (<50%) without stenosis of other major feeding arteries.
• Subjects with the manifestations of chronic cerebral hypoperfusion, such as dizziness, head pain, memory loss, slow reaction, inattention, emotional instability, decreased ability to work, sleep disorders and mood disorders, the course of more than 3 months.
• Subjects or their legally authorized representative can provide informed consent.

Exclusion Criteria:

• Stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination.
• Uncontrolled hypertension (systolic blood pressure ≥200mmHg) with antihypertensive drugs before enrollment, other cardiovascular diseases.
• History of pulmonary, hepatic, dermatologic, or hematologic diseases.
• History of substance abuse.
• Pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Patients; The intermittent hypoxia protocol refers to four cycles of 5 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days.	Other: Intermittent Hypoxia; The intermittent hypoxia protocol refers to four cycles of 5 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days.

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 (according to the Lake Louise scoring system), and insomnia.	After the 7-day treatment.
Incidence of adverse reactions	Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.	Thirty days after the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue oxygen saturation	Including peripheral oxygen saturation and brain tissue oxygen saturation (%).	Baseline, after the 7-day treatment, 30 days after the treatment.
Cerebral blood flow	Cerebral blood flow will be detected by transcranial color-coded duplex sonography.	Baseline, after the 7-day treatment.
Neurobehavioral scale 1	It is evaluated by scales of Mini-mental State Examination (MMSE), which ranges from 0-30 points, and higher scores mean a worse outcome.	Baseline, after the 7-day treatment.
Blood pressure	Including systolic blood pressure and diastolic blood pressure (mmHg).	Baseline, after the 7-day treatment, 30 days after the treatment.
Neurobehavioral scale 2	It is evaluated by scales of Montreal Cognitive Assessment (MoCA), which ranges from 0-30 points, and higher scores mean a worse outcome.	Baseline, after the 7-day treatment.

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2023
• Primary Completion (Anticipated): September 10, 2023
• Study Completion (Anticipated): October 10, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: IH-CCH

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