Skip to main content
Clinical Trials/NCT06686238
NCT06686238
Not yet recruiting
Not Applicable

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

Sierra Varona SL1 site in 1 country16 target enrollmentDecember 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Older Adults
Sponsor
Sierra Varona SL
Enrollment
16
Locations
1
Primary Endpoint
Heart rate variability
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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%.

Registry
clinicaltrials.gov
Start Date
December 5, 2024
End Date
December 26, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Blood pressure(Immediately before intervention and immediately after intervention)
  • Arterial oxygen saturation(Immediately before intervention and immediately after intervention)

Study Sites (1)

Loading locations...

Similar Trials