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

The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects

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

Study Overview

• Status: Completed
• Conditions: Sleep; High Altitude Pulmonary Hypertension
• Intervention / Treatment: Procedure: Nocturnal rest (sleep study)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital of Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High altitude 2500 m above sea level	Procedure: Nocturnal rest (sleep study); Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .
Active Comparator: Low altitude 470 m above sea level	Procedure: Nocturnal rest (sleep study); Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal oxygenation	Difference in mean nocturnal oxygenation (SpO2) 2500 m of high altitude vs 490 m low altitude	30 hours
Oxygen desaturation index	Difference in oxygen desaturation index sleeping at 2500 m high altitude vs 490 m low altitude	30 hours
Periodic breathing	Difference in time spent with periodic breathing in patients sleeping at 2500 m of high altitude vs 490 m low altitude	30 hours
Nocturnal transcutaneous carbon dioxide tension	Difference in nocturnal transcutaneous carbon dioxide tension in patients sleeping at 2500 m of high altitude vs 490 m low altitude	30 hours
Visual Analogue Scale	Subjective sleep quality Visual Analogue Scale score 2500 m high altitude vs 490 m low altitude	30 hours
Time spent awake during the night	Subjective time spent awake during the night high altitude vs 490 m low altitude	30 hours
Cerebral tissue deoxygenation	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	30 hours
Cerebral tissue oxygen saturation awake	Difference in cerebral tissue oxygen saturation awake in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude	30 hours
Cerebral tissue oxygen saturation during sleep without oxygen	Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen	30 hours
Cerebral tissue oxygen saturation during sleep with oxygen	Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude with supplemental oxygen	30 hours
Cerebral oxygen desaturation index without oxygen	Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude	30 hours
Cerebral oxygen desaturation index with oxygen	Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude under supplemental oxygen.	30 hours
Cerebral tissue oxygen saturation between different sleep stages	Changes in the cerebral tissue oxygen saturation between different sleep stages at 2500 m compared to low altitude.	30 hours

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: OVERALP II E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No