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NCT Number: NCT06686238

Acute 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, 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 placebo group will undergo a 5-cycle protocol with an FiO2 of 21%.

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Key information

Conditions

Older Adults Behavior Blood Pressure Cardiovascular Health Sedentary Sedentary Behavior

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Residencial Montes de Toledo

Manzaneque, Toledo, 45460, Spain

Location contact

Alberto Sánchez

SUB_INVESTIGATOR

Arturo Ladriñán

CONTACT

[email protected]

925 26 88 00

Arturo Ladriñán

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being over 60 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

MITOVIT® Hypoxic Training System

Device

The EG (Experimental Group) will undergo a single session of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) session 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

Other names: Hypoxic-Hyperoxic Exposure

Sham MITOVIT® Hypoxic Training System

Device

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.

Other names: Sham Hypoxic-Hyperoxic Exposure

Primary outcomes

  1. Heart rate variability

    Time frame: Immediately before intervention and immediately after 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: Immediately before intervention and immediately after 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: Immediately before intervention and immediately after intervention

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

Study contacts

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

Arturo Ladriñán

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

Acute Effects of a Hypoxia-hyperoxia Exposure Session on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, and Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
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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