Clinical Trial

Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

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Record status
This record was last updated November 27, 2024 (before its estimated January 28, 2025 completion). Its status may not reflect the trial's current state.
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, 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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-11.
Trial Details
NCT Number NCT06686316
Lead Sponsor Sierra Varona SL
Collaborators: Universidad Europea de Madrid
Conditions Sedentary Behavior, Frailty, Older Adults
Enrollment 16 participants
Start Date 2024-12-10
Primary Completion 2025-01-28 (estimated)
Study Completion 2025-02-05 (estimated)
Updated on ClinicalTrials.gov 2024-11-27