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NCT Number: NCT06686316

Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation.

According to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, inflammatory biomarkers, blood pressure, and arterial oxygen saturation.

The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The sham group will undergo a 5-cycle protocol with an FiO2 of 21%.

Both groups will follow a 6-week protocol with three weekly sessions (Monday, Wednesday, and Friday).

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Key information

Conditions

Sedentary Behavior Behavior Frailty Older Adults Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being over 65 years old.
  • Having no previous experience in hypoxic training.
  • Engaging in less than 150 minutes of physical activity per week.

Exclusion criteria

  • Having any pathology that prevents the subject from being independent in terms of walking and functionality.
  • Subjects with impaired cognitive abilities.
  • Subjects with pulmonary hypertension, decompensated heart or respiratory disease.
  • To have or have had cancer

Treatment and study plan

Device: Hypoxic Gas Mixture

Device

The EG (Experimental Group) will undergo a 6-week intervention protocol of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). They will breathe air with an oxygen concentration (FiO2) ranging from 10-14% for 5 minutes, followed by 3 minutes of rest in hyperoxia (FiO2 30-40%), for a total of 6 cycles. During the hypoxic phase, oxygen saturation will be maintained between 85-92%, while during the hyperoxic phase, it will be kept above 95%. This process is regulated by the device's AI. Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the intervention

Sham Hypoxic-Hyperoxic exposure

Other

The Sham Group (SG) will follow a single session protocol of 5 cycles of 6 minutes per session with an FiO2 of 21% using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the placebo intervention.

Primary outcomes

  1. Heart rate variability

    Time frame: 24 hours before intervention and 24 hours after 6 week intervention

    The analysis of Heart Rate Variability will be conducted using a heart rate monitor. Cardiac electrical signals will be monitored with a band placed on the chest for 5 minutes with the subject in supine position on a stretcher, in a quiet environment, soft light, and a comfortable temperature. Subjects are instructed not to speak or make voluntary movements during this analysis.

Secondary outcomes

  1. Blood pressure

    Time frame: 24 hours before intervention and 24 hours after 6 week intervention

    Both systolic and diastolic blood pressure will be assesed using a standard digital sphygmomanometer (Omron HEM-705CP, Omron Healthcare, Inc, Lake Forest, IL)

  2. Arterial oxygen saturation

    Time frame: 24 hours before intervention and 24 hours after 6 week intervention

    Arterial oxygen saturation will be assessed using a device Nonin® 3230 (Nonin Medical, Inc. Plymouth, MN, EEUU)

  3. Respiratory muscle strength

    Time frame: 24 hours before intervention and 24 hours after 6 week intervention

    It will be assessed using a MicroRPM® (MicroMedical, UK).The MicroRPM® is likely a respiratory pressure meter or manometer designed for measuring respiratory muscle strength. It typically includes a mouthpiece connected to a pressure sensor, and the device measures the force or pressure generated during respiratory maneuvers. The person will be instructed to take a maximal deep breath in, and then exhale to residual volume. After that, they will be asked to inhale forcefully against the resistance provided by the MicroRPM®. This measures the strength of the inspiratory muscles. The measures will be expressed in cmH2O.

  4. Pulmonary function

    Time frame: 24 hours before intervention and 24 hours after 6 week intervention

    Pulmonary function tests will be conducted using the Air Smart Spirometer (Pond Healthcare Innovation, Sweden) following the criteria set by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Measurements included Forced Vital Capacity (FVC) and forced expiratory volume in one second (FEV1), expressed in milliliters, as well as the FEV1/FVC ratio

  5. Inflammatory biomarkers

    Time frame: 24 hours before intervention and 24 hours after 6 week intervention

    C-reactive protein concentration measurements will be taken. A nurse will collect venous blood samples from the antecubital vein after a minimum of 10 hours of overnight fasting. The samples will be centrifuged at 1,800 rpm to extract the serum, which will be stored at -80°C. For analysis, an ELISA microplate reader (SpectraMax PLUS 384, Molecular Devices, San Jose, CA, USA) will be used, following the manufacturer's instructions.

Study contacts

Contact information is provided by the study sponsor or research team.

Arturo Ladriñan

CONTACT

[email protected]

925 26 88 00

Sponsors and collaborators

Lead sponsor

Sierra Varona SL

Other

Collaborators

  • Universidad Europea de Madrid

Registry information

Official study title

Effects of a 6-week Hypoxia-hyperoxia Exposure Protocol on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, Respiratory Muscle Strength, Pulmonary Function, Inflammatory Biomarkers and Arterial Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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