Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion

NCT05824104 | Unknown

• 1 other identifier: IH-CCH
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Cerebral Hypoperfusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Tissue oxygen saturation

  Baseline, after the 7-day treatment, 30 days after the treatment.

• Cerebral blood flow

  Baseline, after the 7-day treatment.

• Neurobehavioral scale 1

  Baseline, after the 7-day treatment.

• Blood pressure

  Baseline, after the 7-day treatment, 30 days after the treatment.

• Neurobehavioral scale 2

  Baseline, after the 7-day treatment.

Study Arms (1)

Patients

EXPERIMENTAL

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

Interventions

Intermittent Hypoxia OTHER

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.

Patients

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Central Study Contacts

Yuan Wang, M.D.

CONTACT

+86-135 8156 7815; wilma0106@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 21, 2023
• Study Start: May 10, 2023
• Primary Completion: September 10, 2023
• Study Completion: October 10, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share