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A randomised controlled trial investigating the cardiorespiratory effects of a single hypoxia-hyperoxia exposure session in elderly adults.

Influence of a hypoxia-hyperoxia exposure session on elderly participants cardiorespiratory condition, blood pressure, and oxygen saturation. Randomized double-blind placebo-controlled clinical trial'.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000130561
Enrollment
16
Registered
2024-02-13
Start date
2024-02-22
Completion date
2024-02-27
Last updated
2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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%.

Interventions

The EG (Experimental Group) will undergo asingle session of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) session using the Energy/iAltitude® device (iAltitude Training S.L., Fuenlabrada, Madrid, Spain). They will breathe air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, followed by 1-3 minutes of rest in hyperoxia (FiO2 30-40%), for a total of 4-8 cycles, depending on their acute response to hypoxia. Participants will be asked to sit and breath normally in each expo

The EG (Experimental Group) will undergo asingle session of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) session using the Energy/iAltitude® device (iAltitude Training S.L., Fuenlabrada, Madrid, Spain). They will breathe air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, followed by 1-3 minutes of rest in hyperoxia (FiO2 30-40%), for a total of 4-8 cycles, depending on their acute response to hypoxia. Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the intervention

Sponsors

Universidad Europea de Madrid
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
60 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

• Being over 60 years old. • Having no previous experience in hypoxic training.

Exclusion criteria

• Having any pathology that prevents the performance of physical activity. • Subjects with impaired cognitive abilities. • Subjects with pulmonary hypertension, decompensated heart or respiratory failure. • Subjects who have undergone lower limb surgery within the past 12 months.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026