The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
| Registry | NCT05089487 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, crossover, masking: none, screening |
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| Enrollment | 28 (Actual) |
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| Sponsor | University of Zurich (Other) |
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| Conditions | High Altitude Pulmonary Hypertension, Sleep |
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| Interventions | Nocturnal rest (sleep study) (Procedure) |
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| Dates | start 2021-10-18, primary completion 2022-04-15, completion 2022-04-15, first posted 2021-10-22, last updated 2022-05-11 |
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| Locations | 1 site in Switzerland |
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Related Papers Related Patents Related Grants Related Experts
All trials for High Altitude Pulmonary Hypertension All trials for Sleep All trials of Nocturnal rest (sleep study)
-Summary
The impact of hypoxia at 2500m of high altitude on sleep in patients with precapillary pulmonary hypertension
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
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| High altitude 2500 m above sea level | Experimental | Procedure: Nocturnal rest (sleep study) | |
| Low altitude 470 m above sea level | Active comparator | Procedure: Nocturnal rest (sleep study) | |
- Nocturnal rest (sleep study) (Procedure): Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .
+Outcome measures
Primary outcomes
- Proportion of patients free of severe hypoxemia [30 hours]: Proportion of patients free of severe hypoxemia (defined as oxygenation (SpO2)<80% for >30 min) without oxygen therapy during nocturnal rest at 2500 m vs. 490 m
Secondary outcomes
- Nocturnal oxygenation [30 hours]: Difference in mean nocturnal oxygenation (SpO2) 2500 m of high altitude vs 490 m low altitude
- Oxygen desaturation index [30 hours]: Difference in oxygen desaturation index sleeping at 2500 m high altitude vs 490 m low altitude
- Periodic breathing [30 hours]: Difference in time spent with periodic breathing in patients sleeping at 2500 m of high altitude vs 490 m low altitude
- Nocturnal transcutaneous carbon dioxide tension [30 hours]: Difference in nocturnal transcutaneous carbon dioxide tension in patients sleeping at 2500 m of high altitude vs 490 m low altitude
- Visual Analogue Scale [30 hours]: Subjective sleep quality Visual Analogue Scale score 2500 m high altitude vs 490 m low altitude
- Time spent awake during the night [30 hours]: Subjective time spent awake during the night high altitude vs 490 m low altitude
- Cerebral tissue deoxygenation [30 hours]: Proportion of patients free of severe cerebral tissue deoxygenation (drop in cerebral tissue oxygen saturation >5%) without oxygen therapy during a night at 2500 vs. 490 m
- Cerebral tissue oxygen saturation awake [30 hours]: Difference in cerebral tissue oxygen saturation awake in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude
- Cerebral tissue oxygen saturation during sleep without oxygen [30 hours]: Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen
- Cerebral tissue oxygen saturation during sleep with oxygen [30 hours]: Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude with supplemental oxygen
- Cerebral oxygen desaturation index without oxygen [30 hours]: Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude
- Cerebral oxygen desaturation index with oxygen [30 hours]: Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude under supplemental oxygen.
- Cerebral tissue oxygen saturation between different sleep stages [30 hours]: Changes in the cerebral tissue oxygen saturation between different sleep stages at 2500 m compared to low altitude.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Exclusion Criteria:
* resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
+Locations (1)
| Facility | City | Country | Status |
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| University Hospital of Zurich | Zurich | Switzerland | |
+Publications
- Results publication: Lichtblau M, Schwarz EI, Ulrich T, Schneider SR, Bauer M, Furian M, Carta A, Forrer A, Saxer S, Muller J, Preiss H, Mayer L, Bloch KE, Ulrich S. Effect of an Overnight Stay at 2,500 Meters on Nocturnal Hypoxemia and Sleep-disordered Breathing in Patients with Pulmonary Vascular Disease: A Randomized Clinical Trial. Ann Am Thorac Soc. 2025 Jul;22(7):1053-1061. doi: 10.1513/AnnalsATS.202412-1279OC. PMID 40085143