Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

NCT06686238 | Not Yet Recruiting

• 1 other identifier: 015
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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%.

Conditions

Older Adults; Cardiovascular Health; Blood Pressure; Sedentary

Keywords

hypoxic exposure; older adults; heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately before intervention and immediately after intervention

Secondary Outcomes (2)

• Blood pressure

  Immediately before intervention and immediately after intervention

• Arterial oxygen saturation

  Immediately before intervention and immediately after intervention

Study Arms (2)

Hypoxic-Hyperoxic group

EXPERIMENTAL

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

Sham Hypoxic-Hyperoxic Group

SHAM COMPARATOR

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

Interventions

MITOVIT® Hypoxic Training System DEVICE

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

Hypoxic-Hyperoxic group

Sham MITOVIT® Hypoxic Training System DEVICE

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

Sham Hypoxic-Hyperoxic Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sierra Varona SL: lead
• Universidad Europea de Madrid: collaborator

Study Sites (1)

Residencial Montes de Toledo

Manzaneque, Toledo, 45460, Spain

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Arturo Ladriñán

CONTACT

925 26 88 00; arturo.ladrinan@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: December 5, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 26, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)