Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

NCT06686316 | Not Yet Recruiting

• 1 other identifier: 016
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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, 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).

Conditions

Sedentary Behavior; Frailty; Older Adults

Keywords

hypoxic training; elderly; 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.

  24 hours before intervention and 24 hours after 6 week intervention

Secondary Outcomes (5)

• Blood pressure

  24 hours before intervention and 24 hours after 6 week intervention

• Arterial oxygen saturation

  24 hours before intervention and 24 hours after 6 week intervention

• Respiratory muscle strength

  24 hours before intervention and 24 hours after 6 week intervention

• Pulmonary function

  24 hours before intervention and 24 hours after 6 week intervention

• Inflammatory biomarkers

  24 hours before intervention and 24 hours after 6 week intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

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

Intervention group

Sham Hypoxic-Hyperoxic exposure OTHER

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.

Control group

Eligibility Criteria

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

You may qualify if:

• Being over 65 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

MeSH Terms

Conditions

Sedentary Behavior; Frailty

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arturo Ladriñan

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 10, 2024
• Primary Completion: January 28, 2025
• Study Completion: February 5, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share