Effects of Intermittent Hypoxia-Hyperoxia in Older Adults
NCT ID: NCT06686316
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
16 participants
INTERVENTIONAL
2024-12-10
2025-02-05
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group
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: Hypoxic Gas Mixture
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
Control group
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.
Sham Hypoxic-Hyperoxic exposure
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.
Interventions
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Device: Hypoxic Gas Mixture
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
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.
Eligibility Criteria
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Inclusion Criteria
* Having no previous experience in hypoxic training.
* Engaging in less than 150 minutes of physical activity per week.
Exclusion Criteria
* Subjects with impaired cognitive abilities.
* Subjects with pulmonary hypertension, decompensated heart or respiratory disease.
* To have or have had cancer
65 Years
90 Years
ALL
No
Sponsors
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Universidad Europea de Madrid
OTHER
Sierra Varona SL
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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016
Identifier Type: -
Identifier Source: org_study_id