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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSilvia Ulrich Somaini

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years or >80 years

unstable condition

Patients who cannot follow the study investigations

Patient permanently living < 2600m.

Trial design

Design model

Single group

Treatments tested in this trial

  • Descent to sea level

    Behavioral

    Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Sleep-parameters at 2850m and at sea levelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Silvia Ulrich Somaini

Lead sponsor

University of Zurich

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: