Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH

N/ANot Yet RecruitingNCT07801963

Silvia Ulrich Somaini20 enrolled

Overview

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on sleeping parameters by polygraphy in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.

The aim of this research is to investigate sleeping parameters by polygraphy before and after relocation (high altitude near their living altitude vs. sea level) in patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension (PAH)Pulmonary Vascular Disease Polygraphy Sleep Sleep Disordered Breathing (SDB)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients aged 18-80 years and of all genders * Permanent residence \> 2600 m * Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines * Patients are stable on therapy * NYHA (new york heart association) functional class I-III. * written informed consent to participate in the study. Exclusion Criteria: * Age \<18 years or \>80 years * unstable condition * Patients who cannot follow the study investigations * Patient permanently living \< 2600m. * Patients who traveled and stayed overnight at altitudes \<2000 m in the past 4 weeks. * Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, severe smokers (\>20 cigarettes/day) * Severely hypoxemic patients at Quito permanently having persistent SpO2 (oxygen saturation by pulseoximetry) \<80% on ambient air. * Patient with a non-corrected ventricular septum defect * Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)

Outcomes

Primary Outcomes

Mean nocturnal SpO2 after 7 days at sea level

Difference in mean nocturnal SpO2 between 2850m and Night 7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to night 7 at sea level

Secondary Outcomes

Time spent with low SpO2 after 7 days at sea level

Difference/change in time spent with low SpO2 (\< 90% and \< 80%) between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to night 7 at sea level

Apnoea-Hypopnoea-Index AHI after 7 days at sea level

Difference/change in nocturnal apnoea-hypopnoea-index between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to night 7 at sea level

Oxygen-Desaturation-Index ODI after 7 days at sea level

Difference/change in nocturnal Oxygen-Desaturation-Index ODI between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to night 7 at sea level

Nocturnal cardiovascular autonomic control after 7 days at sea level

Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to night 7 at sea level

Acclimatization-Effect of mean nocturnal SpO2 at sea level

Difference/change in mean nocturnal SpO2 at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in patients with pulmonary arterial hypertension