AdultNCT03728114
Effects of RIC on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude
A study testing RIC in people with Adult, run by Affiliated Hospital to Academy of Military Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adult
- What is being tested?
- RIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Remote Ischemic Conditioning on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude
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.
Read the 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.
- Conditions
- Adult
- Being tested
- RIC, sham RIC
- Keywords
- adult, remote ischemic conditioning, high altitude condition, cognitive function, blood oxygen levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICDevice
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 RICDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High Altitude RIC group | Experimental | 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) Receives: Device: RIC |
| High Altitude Sham group | Sham comparator | 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. Receives: Device: sham RIC |
| Low Altitude RIC group | Experimental | 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. Receives: Device: RIC |
| Low Altitude Sham group | Sham comparator | 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. Receives: Device: sham RIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional network test
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.
Measured: change from baseline (pre-RIC treatment) at 7days after RIC treatment
Secondary outcomes (18)
basic fibroblast growth factor
basic fibroblast growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.
Measured: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
platelet derived growth factor
platelet derived growth facto will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.
Measured: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
vascular endothelial growth factor
vascular endothelial growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.
Measured: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
the rate of Adverse event
Any adverse event will be reported and its relationship with the RIC intervention will be evaluated.
Measured: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
distal radial pulses
It is an aspect which can reflect the safety of remote ischemic conditioning
Measured: within 7 days after RIC treatment
the number of erythema in the skin
It is an aspect which can reflect the safety of remote ischemic conditioning
Measured: within 7 days after RIC treatment
the number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
it is an aspect which can reflect the safety of remote ischemic conditioning
Measured: within 7 days after RIC treatment
the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator.
it is an aspect which can reflect the safety of remote ischemic conditioning
Measured: within 7 days after RIC treatment
heart rate
the heart rate will be measured by automatic blood pressure monitor
Measured: change from baseline(pre-RIC treatment) at 7days after RIC treatment
blood pressure
Both systolic, and diastolic pressure will be measured by automatic blood pressure monitor
Measured: change from baseline(pre-RIC treatment) at 7days after RIC treatment
blood oxygen saturation (SaO2)
The portable oxygen saturation ward apparatus (Datex -Ohmeda, USA) will be used to monitor the blood oxygen saturation (SaO2)
Measured: change from baseline(pre-RIC treatment) at 7days after RIC treatment
cerebral oxygen saturation(TOI)
The cerebral oxygen monitor (EGOS-600, Jiangsu China) will be used to monitor the cerebral oxygen saturation (TOI).
Measured: change from baseline(pre-RIC treatment) at 7days after RIC treatment
The peak systolic blood flow velocity (PSV) of bilateral middle cerebral artery (MCA)
This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards
Measured: change from baseline(pre-RIC treatment) at 7days after RIC treatment
end-diastolic blood flow velocity (EDV) of bilateral middle cerebral artery (MCA)
This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards
Measured: change from baseline(pre-RIC treatment) at 7days after RIC treatment
the mean flow velocity (MFV) of the subjects' bilateral middle cerebral artery (MCA)
This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards
Measured: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
pulse index (PI) of the subjects' bilateral middle cerebral artery (MCA)
This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards
Measured: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
The degree of palpation of tenderness--visual analogue scale
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)
Measured: within 7 days after RIC treatment
the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator
it is an aspect which can reflect the safety of remote ischemic conditioning
Measured: within 7 days after RIC treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
- Investigators
- Lian Duan, MD PHD, Study chair, The 307th Hospital of Military Chinese People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728114
- Sponsor's protocol ID
- ERIC-HA
- Status last verified
- Nov 2018
- First submitted
- 25 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6.
PubMed 19161909Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
PubMed 23035060Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
PubMed 25956401Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
PubMed 11970796Posner MI, Petersen SE. The attention system of the human brain. Annu Rev Neurosci. 1990;13:25-42. doi: 10.1146/annurev.ne.13.030190.000325. No abstract available.
PubMed 2183676Godfrey E, Chalder T, Ridsdale L, Seed P, Ogden J. Investigating the active ingredients of cognitive behaviour therapy and counselling for patients with chronic fatigue in primary care: developing a new process measure to assess treatment fidelity and predict outcome. Br J Clin Psychol. 2007 Sep;46(Pt 3):253-72. doi: 10.1348/014466506X147420.
PubMed 17697477Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
PubMed 29042490Twomey R, Wrightson J, Fletcher H, Avraam S, Ross E, Dekerle J. Exercise-induced Fatigue in Severe Hypoxia after an Intermittent Hypoxic Protocol. Med Sci Sports Exerc. 2017 Dec;49(12):2422-2432. doi: 10.1249/MSS.0000000000001371.
PubMed 28708702
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Conditioning on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude
- ClinicalTrials.gov ID
- NCT03728114
- Acronym / sponsor ID
- ERIC-HA
- Conditions
- Adult
- Keywords
- adult, remote ischemic conditioning, high altitude condition, cognitive function, blood oxygen levels
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Altitude RIC group | Experimental | Device: RICThirty 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) |
| High Altitude Sham group | Sham comparator | Device: sham RICThirty 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. |
| Low Altitude RIC group | Experimental | Device: RICThirty 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. |
| Low Altitude Sham group | Sham comparator | Device: sham RICThirty 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RICAdults 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. | Device | High Altitude RIC group, Low Altitude RIC group |
| sham RICAdults 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. | Device | High Altitude Sham group, Low Altitude Sham group |
Primary outcome
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.
18 secondary outcomes
basic fibroblast growth factor
Time frame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
platelet derived growth factor
Time frame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
vascular endothelial growth factor
Time frame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
the rate of Adverse event
Time frame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
distal radial pulses
Time frame: within 7 days after RIC treatment
the number of erythema in the skin
Time frame: within 7 days after RIC treatment
the number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Time frame: within 7 days after RIC treatment
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
heart rate
Time frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
blood pressure
Time frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
blood oxygen saturation (SaO2)
Time frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
cerebral oxygen saturation(TOI)
Time frame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
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
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
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
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
The degree of palpation of tenderness--visual analogue scale
Time frame: within 7 days after RIC treatment
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 19161909Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6.
- Background: PubMed 23035060Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
- Background: PubMed 25956401Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
- Background: PubMed 11970796Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
- Background: PubMed 2183676Posner MI, Petersen SE. The attention system of the human brain. Annu Rev Neurosci. 1990;13:25-42. doi: 10.1146/annurev.ne.13.030190.000325. No abstract available.
- Background: PubMed 17697477Godfrey E, Chalder T, Ridsdale L, Seed P, Ogden J. Investigating the active ingredients of cognitive behaviour therapy and counselling for patients with chronic fatigue in primary care: developing a new process measure to assess treatment fidelity and predict outcome. Br J Clin Psychol. 2007 Sep;46(Pt 3):253-72. doi: 10.1348/014466506X147420.
- Background: PubMed 29042490Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
- Background: PubMed 28708702Twomey R, Wrightson J, Fletcher H, Avraam S, Ross E, Dekerle J. Exercise-induced Fatigue in Severe Hypoxia after an Intermittent Hypoxic Protocol. Med Sci Sports Exerc. 2017 Dec;49(12):2422-2432. doi: 10.1249/MSS.0000000000001371.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lian Duan, MD PHD study chair
The 307th Hospital of Military Chinese People's Liberation Army
Questions about this trial
What is this clinical trial studying?
A study testing RIC in people with Adult, run by Affiliated Hospital to Academy of Military Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lian Duan, MD PHD (861013911365592, duanlian307@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional network test (time frame: change from baseline (pre-RIC treatment) at 7days after RIC treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03728114, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.