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Effects of RIC on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude

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ClinicalTrials.gov Identifier: NCT03728114
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Xuanwu Hospital, Beijing
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary:
Several studies have shown cognitive impairment such as memory, perception and learning skill during ascent to high altitudes. However, few studies have directly investigated the effect of high altitudes exposure on attention—a high-level cognitive function. Remote ischemic conditioning (RIC) is a noninvasive and easy‐to‐use neuroprotective strategy, It has been proven to be an effective strategy for neuroprotection in ischemic stroke and chronic cerebral ischemia patients.

Condition or disease Intervention/treatment Phase
Adult Device: RIC Device: sham RIC Not Applicable

Detailed Description:
This study will provide insights into the preliminary proof of principle, safety, cognitive dysfunction and blood oxygen levels protective effects of RIC in Adults Exposing to High Altitude Conditions, and this data will provide parameters for future larger scale clinical trials if efficacious.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Remote Ischemic Conditioning on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: High Altitude RIC group
Thirty young healthy males from the altitude of 3700 meters will be allocated to the High Altitude RIC group. They will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days. The treatment was carried out using an electric auto-control device (patent number ZL200820123637.X, China)
Device: RIC
Adults allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.

Sham Comparator: High Altitude Sham group
Thirty young healthy males from the altitude of 3700 meters will be allocated to the High Altitude Sham group. They will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days.
Device: sham RIC
Adults allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.

Experimental: Low Altitude RIC group
Thirty young healthy males from the altitude of 42 meters will be allocated to the Low Altitude RIC group. They will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days. The treatment was carried out using an electric auto-control device.
Device: RIC
Adults allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.

Sham Comparator: Low Altitude Sham group
Thirty young healthy males from the altitude of 42 meters will be allocated to the Low Altitude Sham group. They will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days.
Device: sham RIC
Adults allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.




Primary Outcome Measures :
  1. Attentional network test [ Time Frame: change from baseline (pre-RIC treatment) at 7days after RIC treatment ]
    The computer software attentional network test (ANT) as described by Fan et al. in 2002 will be used to measuring the Orienting function, executive function and alerting function.


Secondary Outcome Measures :
  1. basic fibroblast growth factor [ Time Frame: change from baseline (pre‐RIC treatment) at 7 days after RIC treatment ]
    basic fibroblast growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.

  2. platelet derived growth factor [ Time Frame: change from baseline (pre‐RIC treatment) at 7 days after RIC treatment ]
    platelet derived growth facto will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.

  3. vascular endothelial growth factor [ Time Frame: change from baseline (pre‐RIC treatment) at 7 days after RIC treatment ]
    vascular endothelial growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.

  4. the rate of Adverse event [ Time Frame: change from baseline (pre‐RIC treatment) at 7 days after RIC treatment ]
    Any adverse event will be reported and its relationship with the RIC intervention will be evaluated.

  5. distal radial pulses [ Time Frame: within 7 days after RIC treatment ]
    It is an aspect which can reflect the safety of remote ischemic conditioning

  6. the number of erythema in the skin [ Time Frame: within 7 days after RIC treatment ]
    It is an aspect which can reflect the safety of remote ischemic conditioning

  7. the number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure [ Time Frame: within 7 days after RIC treatment ]
    it is an aspect which can reflect the safety of remote ischemic conditioning

  8. the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator. [ Time Frame: within 7 days after RIC treatment ]
    it is an aspect which can reflect the safety of remote ischemic conditioning

  9. heart rate [ Time Frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment ]
    the heart rate will be measured by automatic blood pressure monitor

  10. blood pressure [ Time Frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment ]
    Both systolic, and diastolic pressure will be measured by automatic blood pressure monitor

  11. blood oxygen saturation (SaO2) [ Time Frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment ]
    The portable oxygen saturation ward apparatus (Datex -Ohmeda, USA) will be used to monitor the blood oxygen saturation (SaO2)

  12. cerebral oxygen saturation(TOI) [ Time Frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment ]
    The cerebral oxygen monitor (EGOS-600, Jiangsu China) will be used to monitor the cerebral oxygen saturation (TOI).

  13. The peak systolic blood flow velocity (PSV) of bilateral middle cerebral artery (MCA) [ Time Frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment ]
    This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards

  14. end-diastolic blood flow velocity (EDV) of bilateral middle cerebral artery (MCA) [ Time Frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment ]
    This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards

  15. the mean flow velocity (MFV) of the subjects' bilateral middle cerebral artery (MCA) [ Time Frame: change from baseline (pre‐RIC treatment) at 7 days after RIC treatment ]
    This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards

  16. pulse index (PI) of the subjects' bilateral middle cerebral artery (MCA) [ Time Frame: change from baseline (pre‐RIC treatment) at 7 days after RIC treatment ]
    This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards

  17. The degree of palpation of tenderness--visual analogue scale [ Time Frame: within 7 days after RIC treatment ]
    The degree of palpation of tenderness is an aspect which can reflect the safety of remote ischemic conditioning. The pain was assessed with visual analogue scale ( VAS)

  18. the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator [ Time Frame: within 7 days after RIC treatment ]
    it is an aspect which can reflect the safety of remote ischemic conditioning



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The age was between 19 and 30 years.
  • All participants should meet the criteria which included right-hand dominance, normal or corrected-to-normal vision.
  • the RIC group volunteers have no history of intravascular thrombosis in the bilateral upper limbs;
  • The high altitude participants move into the high-altitude environment within one month, and the low altitude volunteers have long-term life in low altitude areas.

Exclusion Criteria:

  • Severe hepatic or renal dysfunction
  • Severe hemostatic disorder or severe coagulation dysfunction
  • Any of the following cardiac disease ‐ rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation
  • Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
  • Patient participating in a study involving other drug or device trial study 7. Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations 8. Unlikely to be available for follow‐up for 3 months 9. Contraindication for RIC ‐ severe soft‐tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Information from the National Library of Medicine

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): NCT03728114


Contacts
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Contact: Lian Duan, MD PHD 861013911365592 duanlian307@sina.com
Contact: Han Cong, MD MS 861013466346163 hc82225@126.com

Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Xuanwu Hospital, Beijing
Investigators
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Study Chair: Lian Duan, MD PHD The 307th Hospital of Military Chinese People's Liberation Army

Publications:

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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT03728114     History of Changes
Other Study ID Numbers: ERIC-HA
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
adult
remote ischemic conditioning
high altitude condition
cognitive function
blood oxygen levels