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

NCT ID: NCT05089487

Last Updated: 2022-05-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2022-04-15

Brief Summary

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

Detailed Description

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Conditions

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High Altitude Pulmonary Hypertension Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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High altitude 2500 m above sea level

Group Type EXPERIMENTAL

Nocturnal rest (sleep study)

Intervention Type PROCEDURE

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

Low altitude 470 m above sea level

Group Type ACTIVE_COMPARATOR

Nocturnal rest (sleep study)

Intervention Type PROCEDURE

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

Interventions

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Nocturnal rest (sleep study)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 40085143 (View on PubMed)

Other Identifiers

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OVERALP II E

Identifier Type: -

Identifier Source: org_study_id

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