Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

ConditionsSedentary Behavior Frailty 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, 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being over 65 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

Device: Hypoxic Gas Mixture
Device
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
Sham Hypoxic-Hyperoxic exposure
Other 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.

Treatment groups

16 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

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