Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

Not Applicable

Not yet recruiting

• Conditions: Older Adults; Cardiovascular Health; Blood Pressure; Sedentary

• Registration Number: NCT06686238
• Lead Sponsor: Sierra Varona SL

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%.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Study Start: 2024-12-05
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Being over 60 years old.
• Having no previous experience in hypoxic training.
• Engaging in less than 150 minutes of physical activity per week.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart rate variability	Immediately before intervention and immediately after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Immediately before intervention and immediately after intervention	Both systolic and diastolic blood pressure will be assesed using a standard digital sphygmomanometer (Omron HEM-705CP, Omron Healthcare, Inc, Lake Forest, IL)
Arterial oxygen saturation	Immediately before intervention and immediately after intervention	Arterial oxygen saturation will be assessed using a device Nonin® 3230 (Nonin Medical, Inc. Plymouth, MN, EEUU)

Trial Locations

Locations (1)

Residencial Montes de Toledo; 🇪🇸 Manzaneque, Toledo, Spain