NCT02959008

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 5, 2016

Last Update Submit

November 15, 2016

Conditions

Cerebral Blood FlowCerebral Perfusion Pressure

Outcome Measures

Primary Outcomes (1)

  • range of cerebral autoregulation

    30min

Study Arms (2)

normal

Human without hypertension, diabetes, anemia, liver disease and kidney disease. The group will measure TOI and BP.

Device: measure TOI and BP

hypertension

Human only have hypertension, without diabetes, anemia, liver disease and kidney disease. Hypertension group will measure TOI and BP.

Device: measure TOI and BP

Interventions

measure TOI and BPDEVICE

Both groups measure TOI and BP.

hypertensionnormal

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. adult 2. health people 3. people with hypertension

You may qualify if:

  • health people, or people with hypertension

You may not qualify if:

  • diabetes, anemia, liver disease, kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Xiaohong Wu

    Beijing Electric Power Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liyun Yu

CONTACT

13683217693yu_li_yun@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2016

First Posted

November 8, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

November 16, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share