An interventional study of MITOVIT® Hypoxic Training System and Sham MITOVIT® Hypoxic Training System in Older Adults, Cardiovascular Health and Blood Pressure, sponsored by Sierra Varona SL. Not yet recruiting at 1 site in Spain. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Sierra Varona SL · Not applicable, Interventional, and Treatment
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%.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 16 is below the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
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Exclusion Criteria:
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
Device: MITOVIT® Hypoxic Training System
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.
Device: Sham MITOVIT® Hypoxic Training System
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
Also known as: Hypoxic-Hyperoxic Exposure
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.
Also known as: Sham Hypoxic-Hyperoxic Exposure
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 intervention
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 intervention
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 intervention
Plan to share: Yes
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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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