- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02959008
Continous Assessment of Cerebral Autoregulation With Near-infrared Spectroscopy
November 15, 2016 updated by: Yu Liyun
Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the context of changes in cerebral perfusion pressure.
In this study, investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Near-infrared spectroscopy (NIRS) is a noninvasive technology that real-time monitors cerebral tissue oxygenation index (TOI).
Investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation of hypertensive participants and non-hypertensive participants.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- adult
- health people
- people with hypertension
Description
Inclusion Criteria:
- health people, or people with hypertension
Exclusion Criteria:
- diabetes, anemia, liver disease, kidney disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
normal
Human without hypertension, diabetes, anemia, liver disease and kidney disease.
The group will measure TOI and BP.
|
Both groups measure TOI and BP.
|
hypertension
Human only have hypertension, without diabetes, anemia, liver disease and kidney disease. Hypertension group will measure TOI and BP. |
Both groups measure TOI and BP.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
range of cerebral autoregulation
Time Frame: 30min
|
30min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiaohong Wu, Beijing Electric Power Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
November 5, 2016
First Submitted That Met QC Criteria
November 5, 2016
First Posted (Estimate)
November 8, 2016
Study Record Updates
Last Update Posted (Estimate)
November 16, 2016
Last Update Submitted That Met QC Criteria
November 15, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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