Last reviewed · How we verify
NCT06686316
Effects of Intermittent Hypoxia-Hyperoxia in Older Adults
NA trial testing Device: Hypoxic Gas Mixture in Sedentary Behavior in 16 participants. Not yet recruiting.
28 January 2025
Quick facts
| Lead sponsor | Sierra Varona SL |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 10 December 2024 |
| Primary completion | 28 January 2025 |
| Estimated completion | 5 February 2025 |
Drugs / interventions tested
- Device: Hypoxic Gas Mixture
- Sham Hypoxic-Hyperoxic exposure
Conditions studied
- Sedentary Behavior — all drugs for Sedentary Behavior →
- Frailty — all drugs for Frailty →
- Older Adults — all drugs for Older Adults →
Sponsor
Sierra Varona SL
Who can join
Adults 65 to 90, any sex, with Sedentary Behavior or Frailty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of a 6-Week Intermittent Hypoxia-Hyperoxia Exposure Program on Blood Pressure, Respiratory Function, Cardiac Autonomic Nervous Activity and CRP Levels in Older Adults: A Randomized Clinical Trial.
Ladriñán-Maestro A, Sánchez-Sierra A, Herrera-Gómez-Platero M, Sánchez-Infante J. · · 2026 · PMID 41590984 · DOI 10.3390/sports14010042
Verify or expand the search:
- PubMed search for NCT06686316
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06686316 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sierra Varona SL
- Last refreshed: 27 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06686316.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing