Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT07018895
Eligibility Criteria:
Inclusion Criteria:
1. Age 60-74 years.
2. Signed informed consent.
Non-inclusion criteria
1. Charlson Comorbidity Index ≤ 3 (with a score of 1 or more on all criteria except for the age factor).
2. Conditions associated with chronic hypoxia or hyperoxia.
3. Uncompensated coronary artery disease.
4. Chronic diseases in the acute or decompensated phase.
Exclusion Criteria:
1. Withdrawal from further participation in the study (revocation of informed consent), unrelated to any of the subsequent points.
2. Inability to reduce cerebral tissue saturation by 20% from baseline during the hypoxic test.
3. Individual intolerance to IHHT sessions.
4. Development of one of the following complications during IHHT sessions:
1). Disorder of consciousness. 2). The state of syncope. 3). Development of any other life-threatening condition.
The fact and the reason for the Subject to be excluded from the study will be recorded in the CRF (Case Report Form), along with all data collected during the study, for further analysis, if planned.
If exclusion occurs according to points 1 and 2 of the exclusion criteria, the subject will be replaced with another participant. If exclusion occurs according to any of the subsequent points, replacement will not be performed.
If exclusion occurs according to points 3 and 4, patients will be thoroughly examined and remain under the observation of the study physicians until their condition is stabilized
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
74 Years
Study:
NCT07018895
Study Brief:
Protocol Section:
NCT07018895