An interventional study of Device: Hypoxic Gas Mixture and Sham Hypoxic-Hyperoxic exposure in Sedentary Behavior, Frailty and Older Adults, sponsored by Sierra Varona SL. Not yet recruiting. 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, 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).
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.
Browse Sedentary Behavior studies →Sierra Varona SL is the lead sponsor of 16 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
The EG (Experimental Group) will undergo a 6-week intervention protocol with three weekly sessions (Monday, Wednesday, and Friday) 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: Device: Hypoxic Gas Mixture
The Sham Group (SG) will follow a 6-week sham intervention protocol with three weekly sessions (Monday, Wednesday, and Friday) 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.
Other: Sham Hypoxic-Hyperoxic exposure
The EG (Experimental Group) will undergo a 6-week intervention protocol of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) 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
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.
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: 24 hours before intervention and 24 hours after 6 week 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: 24 hours before intervention and 24 hours after 6 week intervention
Arterial oxygen saturation
Arterial oxygen saturation will be assessed using a device Nonin® 3230 (Nonin Medical, Inc. Plymouth, MN, EEUU)
Time frame: 24 hours before intervention and 24 hours after 6 week intervention
Respiratory muscle strength
It will be assessed using a MicroRPM® (MicroMedical, UK).The MicroRPM® is likely a respiratory pressure meter or manometer designed for measuring respiratory muscle strength. It typically includes a mouthpiece connected to a pressure sensor, and the device measures the force or pressure generated during respiratory maneuvers. The person will be instructed to take a maximal deep breath in, and then exhale to residual volume. After that, they will be asked to inhale forcefully against the resistance provided by the MicroRPM®. This measures the strength of the inspiratory muscles. The measures will be expressed in cmH2O.
Time frame: 24 hours before intervention and 24 hours after 6 week intervention
Pulmonary function
Pulmonary function tests will be conducted using the Air Smart Spirometer (Pond Healthcare Innovation, Sweden) following the criteria set by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Measurements included Forced Vital Capacity (FVC) and forced expiratory volume in one second (FEV1), expressed in milliliters, as well as the FEV1/FVC ratio
Time frame: 24 hours before intervention and 24 hours after 6 week intervention
Inflammatory biomarkers
C-reactive protein concentration measurements will be taken. A nurse will collect venous blood samples from the antecubital vein after a minimum of 10 hours of overnight fasting. The samples will be centrifuged at 1,800 rpm to extract the serum, which will be stored at -80°C. For analysis, an ELISA microplate reader (SpectraMax PLUS 384, Molecular Devices, San Jose, CA, USA) will be used, following the manufacturer's instructions.
Time frame: 24 hours before intervention and 24 hours after 6 week intervention
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Jan 2025, 1 month later.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 1 month is below that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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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Sierra Varona SL