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

Not Applicable

Completed

• Conditions: Sleep; High Altitude Pulmonary Hypertension
• Interventions: Procedure: Nocturnal rest (sleep study)

• Registration Number: NCT05089487
• Lead Sponsor: University of Zurich

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-14
• Study Start: 2021-10-18
• Study First Posted: 2021-10-22
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High altitude 2500 m above sea level	Nocturnal rest (sleep study)	-
Low altitude 470 m above sea level	Nocturnal rest (sleep study)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Oxygen desaturation index	30 hours	Difference in oxygen desaturation index sleeping at 2500 m 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 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
Nocturnal oxygenation	30 hours	Difference in mean nocturnal oxygenation (SpO2) 2500 m of 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
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 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
Time spent awake during the night	30 hours	Subjective time spent awake during the night 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
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 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.
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.

Trial Locations

Locations (1)

University Hospital of Zurich; 🇨🇭 Zurich, Switzerland