Acute Exposure of Simulated Hypoxia on Cognitive Function

Not Applicable

Completed

• Conditions: Pulmonary Hypertension

• Registration Number: NCT03637127
• Lead Sponsor: University of Zurich

Brief Summary

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on cognitive functions.

Detailed Description

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.

During the exposure to simulated altitude (FiO2: 15.1%) of approximately 1 hour, the participants will perform cognitive function test .

The results will be compared under hypoxic and normal conditions.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-17
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Informed consent
• PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
• PH class 1 (PAH) or 4 (CTEPH)
• Stable condition, on the same medication for > 4 weeks
• Patient live permanently at an altitude < 1000m asl.

Exclusion Criteria

• Resting partial oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
• Severe daytime hypercapnia (pCO2 > 6.5 kPa)
• Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
• Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
• Residence > 1000m above sea level
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
• Women who are pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cognitive Function test	2 hours	Change in cognitive function test time during the exposure to simulated altitude (FiO2: 15.1%) and normoxia

Trial Locations

Locations (1)

Respiratory Clinic, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland