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Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 27, 2024 (before its estimated December 15, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Interventions: Hypoxic Gas Mixture (Device), Sham (Device) to MITOVIT® Hypoxic Training System (Device), Sham MITOVIT® Hypoxic Training System (Device)
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 2 entries
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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%.
Trial Details
NCT Number NCT06686238
Lead Sponsor Sierra Varona SL
Collaborators: Universidad Europea de Madrid
Conditions
(from sponsor)		 Older Adults, Cardiovascular Health, Blood Pressure, Sedentary
Related terms Sedentary Behavior
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov