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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089487
• Other study ID #: OVERALP II E
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: May 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• High Altitude Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Sleep

Intervention

Procedure:
• Nocturnal rest (sleep study)
Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nocturnal oxygenation	Difference in mean nocturnal oxygenation (SpO2) 2500 m of high altitude vs 490 m low altitude	30 hours
Secondary	Oxygen desaturation index	Difference in oxygen desaturation index sleeping at 2500 m high altitude vs 490 m low altitude	30 hours
Secondary	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
Secondary	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
Secondary	Visual Analogue Scale	Subjective sleep quality Visual Analogue Scale score 2500 m high altitude vs 490 m low altitude	30 hours
Secondary	Time spent awake during the night	Subjective time spent awake during the night high altitude vs 490 m low altitude	30 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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