Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorSierra Varona SL
About this trial
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%.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being over 60 years old.
Having no previous experience in hypoxic training.
Engaging in less than 150 minutes of physical activity per week.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MITOVIT® Hypoxic Training System
DeviceThe 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
Sham MITOVIT® Hypoxic Training System
DeviceThe 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.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Hypoxic-Hyperoxic groupExperimental treatment 1 intervention
Group B: Sham Hypoxic-Hyperoxic GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Heart rate variability
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.
Time frame
Immediately before intervention and immediately after interventionSecondary outcomes
1
Blood pressure
Both systolic and diastolic blood pressure will be assesed using a standard digital sphygmomanometer (Omron HEM-705CP, Omron Healthcare, Inc, Lake Forest, IL)
Time frame
Immediately before intervention and immediately after intervention2
Arterial oxygen saturation
Arterial oxygen saturation will be assessed using a device Nonin® 3230 (Nonin Medical, Inc. Plymouth, MN, EEUU)
Time frame
Immediately before intervention and immediately after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sierra Varona SL
Lead sponsor
Universidad Europea de Madrid
Collaborator
Source ClinicalTrials.gov
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