The Efficacy and Safety of Normobaric Oxygen on Chronic Cerebral Circulation Insufficiency
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03745092|
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Normobaric Oxygen Cerebral Ischemia||Device: normobaric oxygen||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Efficacy and Safety of Normobaric Oxygen on Chronic Cerebral Circulation Insufficiency|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Normobaric oxygen group
Patients who are diagnosed as chronic cerebral circulation insufficiency will be recruited into the normobaric oxygen group to receive NBO (5-8L/min, via nasal cannula or face mask) 1 hour per time, 3 times per day for 6 months, and the other routine medical therapy.
Device: normobaric oxygen
Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by nasal cannula or facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
No Intervention: Control group
Patients in the control group will undergo only routine treatments without NBO for the same period of time.
- White matter lesion scale (Scheltens scales) [ Time Frame: 6 months ]The Scheltens scale has a range from 0-84, where scores 0-6 can be given in periventricular regions, 0-24 in the deep WM, 0-30 in the basal ganglia, and 0-24 in infratentorial regions.
- Patient Global Impression of Change (PGIC) scale [ Time Frame: 2 week ]The PGIC is a self-evaluation of the patient's overall change since the start of the study according to a 7-point Likert scale (1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse).
- Incidence of ischemic events [ Time Frame: 6 months ]The incidence of ischemic events (including recurrent ischemic stroke, TIA, TGA, etc.) after initiation of the intervention,
- headache visual analog scale (Headache VAS) [ Time Frame: 1, 3 and 6 months ]Visual analog scale (VAS) is a method of measuring a subjective construct believed to exist along a continuum. VAS typically takes the form of a straight line of a specific length, usually 100 mm, with extreme descriptors at either end. Individuals rate the characteristic or attitude of interest by placing a mark at a point somewhere along the line that represents their subjective experience. The range of VAS is from 0 (no headache) to 10 (worst possible pain).
- European evaluation of vertigo scale (EEV) [ Time Frame: 1, 3 and 6 months ]The European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that consists of five equally weighted items scored from 0 to 4 on a categorical five-point scale. The following five items are considered : "Illusion of Movement", "Duration of the Illusion", "Motion Intolerance", "Neurovegetative Signs", and "Instability".
- modified Rankin scale (mRS) [ Time Frame: 1, 3 and 6 months ]The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.
- Barthel index (BI) [ Time Frame: 1, 3 and 6 months ]The Barthel scale (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). BI consists of ten items (total 100 scores) describing ADL and mobility. Each performance item is rated on this scale with a given number of points assigned to each level or ranking. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
- Incidence of complications [ Time Frame: 1, 3 and 6 months ]Complications are used to determine the safety of normobaric oxygen on chronic cerebral circulation insufficiency patients, including abnormal symptoms (such as chest pain, dyspnea, insomnia, etc.), respiratory abnormality (infection, respiratory alkalosis, respiratory acidosis, etc.) and cardiovascular diseases (arrhythmia).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745092
|Contact: Ran H Meng, professor||+86-10-83199280 ext +firstname.lastname@example.org|
|Contact: Ran H Meng, professor||+861083199280 ext +email@example.com|
|Xuanwu Hospital, Captial Medical University||Not yet recruiting|
|Beijing, China, 100053|
|Contact: Ran Meng, Professor +86-10-83199280 firstname.lastname@example.org|
|Principal Investigator: Jiayue Ding|
|Principal Investigator: Chaobo Bai|
|Principal Investigator: Da Zhou|
|Principal Investigator: Liqun Pan|
|Principal Investigator: Jingyuan Ya|
|Principal Investigator: Cheng Liu|
|Principal Investigator: Kexin Jin|
|Principal Investigator: Zhongao Wang|
|Principal Investigator: Jingwei Guan|
|Principal Investigator: Jingkun Sun|
|Principal Investigator: Siying Song|