High Altitude, High Altitude Effects, Polygraphy, Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease, Sleep, Sleep Disordered Breathing (SDB)
Conditions
Keywords
Pulmonary Arterial Hypertension (PAH), Hypoxia, High Altitude, Pulmonary Hypertension, Polygraphy, Sleep, Sleep disordered breathing SDB, Pulmonary vascular disease
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALDescent to sea level
Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m
Sponsors
Silvia Ulrich Somaini
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m, after relocation to sea level for 7 days and after re-ascent
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean nocturnal SpO2 after 7 days at sea level | From high altitude (2850m) to night 7 at sea level | Difference in mean nocturnal SpO2 between 2850m and Night 7 at sea level in patients with pulmonary arterial hypertension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen-Desaturation-Index ODI after 7 days at sea level | From high altitude (2850m) to night 7 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 |
| Nocturnal cardiovascular autonomic control after 7 days at sea level | From high altitude (2850m) to night 7 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 |
| Acclimatization-Effect of mean nocturnal SpO2 at sea level | From Night 1 to Night 7 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 |
| Acclimatization-Effect of time spent with low SpO2 at sea level | From Night 1 to Night 7 at sea level | Difference/change in time spent with low SpO2 (\< 90% and \< 80%) 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 |
| Acclimatization-Effect of Apnoea-Hypopnoea-Index AHI at sea level | From Night 1 to Night 7 at sea level | Difference/change in nocturnal apnoea-hypopnoea-index 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 |
| Acclimatization-Effect of Oxygen-Desaturation-Index ODI at sea level | From Night 1 to Night 7 at sea level | Difference/change in nocturnal oxygen-desaturation-index ODI 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 |
| Time spent with low SpO2 after 7 days at sea level | From high altitude (2850m) to night 7 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 |
| Acclimatization-Effect of nocturnal cardiovascular autonomic control at sea level | From Night 1 to Night 7 at sea level | Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) 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 |
| Mean nocturnal SpO2 after re-ascent to 2850m | From Night 7 at sea level to night after reascent (time frame of 3 days) | Difference/change in mean nocturnal SpO2 between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Time spent with low SpO2 after re-ascent to 2850m | From Night 7 at sea level to night after re-ascent (time frame of 3 days) | Difference/change in time spent with low SpO2 (\< 90% and \< 80%) between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Apnoea-Hypopnoea-Index AHI after re-ascent to 2850m | From Night 7 at sea level to night after re-ascent (time frame of 3 days) | Difference/change in nocturnal apnoea-hypopnoea-index between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Oxygen-Desaturation-Index ODI after re-ascent to 2850m | From Night 7 at sea level to night after re-ascent (time frame of 3 days) | Difference/change in nocturnal oxygen-desaturation-index between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Nocturnal cardiovascular autonomic control after re-ascent to 2850m | From Night 7 at sea level to night after re-ascent (time frame of 3 days) | Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between sea level (after one-week stay) and night after re-ascent to 2850m in patients with pulmonary arterial hypertension |
| Mean nocturnal SpO2 pre-descent and after re-ascent (2850m) | From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days) | Difference/change in mean nocturnal SpO2 between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension |
| Time spent with low SpO2 pre-descent and after re-ascent (2850m) | From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days) | Difference/change in time spent with low SpO2 (\< 90% and \< 80%) between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension |
| Apnoea-Hypopnoea-Index AHI pre-descent and after re-ascent (2850m) | From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days) | Difference/change in nocturnal apnoea-hypopnoea-index between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension |
| Oxygen-Desaturation-Index ODI pre-descent and after re-ascent (2850m) | From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days) | Difference/change in nocturnal oxygen-desaturation-index between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension |
| Apnoea-Hypopnoea-Index AHI after 7 days at sea level | From high altitude (2850m) to night 7 at sea level | Difference/change in nocturnal apnoea-hypopnoea-index between 2850m and night 7 at sea level in patients with pulmonary arterial hypertension |
| Nocturnal cardiovascular autonomic control pre-descent and after re-ascent (2850m) | From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days) | Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between the night at 2850 prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in patients with pulmonary arterial hypertension |
Countries
Switzerland
Contacts
CONTACTSilvia Ulrich, Prof. Dr. med.
CONTACTMichael Furian, Prof. Dr. sc. ETH
PRINCIPAL_INVESTIGATORSilvia Ulrich
University Hospital Zurich, Departement of Pulmonology
PRINCIPAL_INVESTIGATORRodrigo Hoyos
Hospital Carlos Andrade Marin of Quito, Ecuador
Outcome results
None listed