Personalized Hypoxic-hyperoxic Preconditioning in Elderly People

NCT07018895 | Completed DMC

• 1 other identifier: SHIELD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates an original protocol of personalized hypoxic-hyperoxic preconditioning utilizing a personalized approach on the basis of cerebral tissue oxygenation assessed with near-infrared spectroscopy. 20 healthy elderly volunteers will be randomized into two equal groups. Subjects of the experimental group will undergo personalized sessions of intermittent hypoxic-hyperoxic training (IHHT) based on the cerebral tissue oximetry index assessed with near-infrared spectroscopy with a target reduction of 20%. Subjects of the control group (sham treatment) will undergo placebo procedures with atmospheric air.

Conditions

Preconditioning

Keywords

OXYTERRA; intermittent hypoxic-hyperoxic training; cerebral tissue oxygenation

Outcome Measures

Primary Outcomes (1)

• Incidence of intolerance to IHHT sessions (a combined endpoint including individual intolerance showing discomfort that does not allow the Subject to continue the IHHT sessions and/or the incidence of one of the complications of IHHT sessions (disorde

  The difference in the incidence of intolerance to IHHT sessions (percent)

  Periprocedural

Secondary Outcomes (24)

• Systolic blood pressure levels (SBP) (mmHg)

  6, 9, 15, 18, 24, 27, 33, 36, and 45 minutes from the initiation of the IHHT session

• Diastolic blood pressure levels (DBP) (mmHg).

  6, 9, 15, 18, 24, 27, 33, 36, and 45 minutes from the initiation of the IHHT session

• Heart rate (HR) (bpm)

  6, 9, 15, 18, 24, 27, 33, 36, and 45 minutes from the initiation of the IHHT session

• Saturation of peripheral oxygen (SpO2) levels (percentage)

  6, 9, 15, 18, 24, 27, 33, 36, and 45 minutes from the initiation of the IHHT session

• Respiratory rate (RR) (brpm)

  6, 9, 15, 18, 24, 27, 33, 36, and 45 minutes from the initiation of the IHHT session

Study Arms (2)

Control group

ACTIVE COMPARATOR

ambient air (FiO2 = 21%) will be delivered for 3 days 1 time a day for 45 minutes

Drug: Sham treatment

Main group

EXPERIMENTAL

FiO2 reduced by 20% will be delivered for 6 minutes alternating with 34% FiO2 for 3 minutes (45 minutes in total as 5 full circles) within 3 days 1 time a day

Drug: FiO2 reduced by 20% alternating with 34% FiO2

Interventions

Sham treatment DRUG

ambient air (FiO2 = 21%) will be delivered for 3 days 1 time a day for 45 minutes

Also known as: ambient air

Control group

FiO2 reduced by 20% alternating with 34% FiO2 DRUG

FiO2 reduced by 20% alternating with 34% FiO2

Also known as: FiO2

Main group

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60-74 years.
• Signed informed consent.
• Charlson Comorbidity Index ≤ 3 (with a score of 1 or more on all criteria except for the age factor).
• Conditions associated with chronic hypoxia or hyperoxia.
• Uncompensated coronary artery disease.
• Chronic diseases in the acute or decompensated phase.

You may not qualify if:

• Withdrawal from further participation in the study (revocation of informed consent), unrelated to any of the subsequent points.
• Inability to reduce cerebral tissue saturation by 20% from baseline during the hypoxic test.
• Individual intolerance to IHHT sessions.
• Development of one of the following complications during IHHT sessions:
• ). 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.

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia

Tomsk, 634012, Russia

Location

Related Publications (1)

• Uzun AB, Iliescu MG, Stanciu LE, Ionescu EV, Ungur RA, Ciortea VM, Irsay L, Motoasca I, Popescu MN, Popa FL, Pazara L, Tofolean DE. Effectiveness of Intermittent Hypoxia-Hyperoxia Therapy in Different Pathologies with Possible Metabolic Implications. Metabolites. 2023 Jan 25;13(2):181. doi: 10.3390/metabo13020181.

  PMID: 36837800 RESULT

MeSH Terms

Interventions

Particulate Matter

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Nikolay O. Kamenshchikov, MD, PhD

  Cardiology Research Institute, Tomsk National Research Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 3, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)