Nocturnal Oxygenation and Sleep-related Breathing Disorders During the First Night of a Stay at 2500m of High Altitude in Patients With Precapillary Pulmonary Hypertension

NCT05089487 | Completed

• 1 other identifier: OVERALP II E
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The impact of hypoxia at 2500m of high altitude on sleep in patients with precapillary pulmonary hypertension

Conditions

High Altitude Pulmonary Hypertension; Sleep

Outcome Measures

Primary Outcomes (1)

• Proportion of patients free of severe hypoxemia

  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

  30 hours

Secondary Outcomes (13)

• Nocturnal oxygenation

  30 hours

• Oxygen desaturation index

  30 hours

• Periodic breathing

  30 hours

• Nocturnal transcutaneous carbon dioxide tension

  30 hours

• Visual Analogue Scale

  30 hours

Study Arms (2)

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)

Interventions

Nocturnal rest (sleep study) PROCEDURE

Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .

High altitude 2500 m above sea level; Low altitude 470 m above sea level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pulmonary edema of mountaineers

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 22, 2021
• Study Start: October 18, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

CH (1)