Acute Exposure of Simulated Hypoxia on Cognitive Function
Anahtar kelimeler
Öz
Açıklama
Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.
Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.
During the exposure to simulated altitude (FiO2: 15.1%) of approximately 1 hour, the participants will perform cognitive function test .
The results will be compared under hypoxic and normal conditions.
Tarih
| Son Doğrulandı: | 12/31/2019 |
| İlk Gönderilen: | 07/08/2018 |
| Tahmini Kayıt Gönderildi: | 08/15/2018 |
| İlk Gönderilen: | 08/16/2018 |
| Son Güncelleme Gönderildi: | 01/05/2020 |
| Son Güncelleme Gönderildi: | 01/06/2020 |
| Fiili Çalışma Başlangıç Tarihi: | 06/30/2018 |
| Tahmini Birincil Tamamlanma Tarihi: | 03/31/2019 |
| Tahmini Çalışma Tamamlanma Tarihi: | 03/31/2019 |
Durum veya hastalık
Müdahale / tedavi
Device: Simulated Altitude (FiO2: 15.1%)
Device: Shamed Hypoxia (FiO2: 20.9)
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Experimental: Order air-hypoxia The participants will be exposed to shamed hypoxia (FiO2: 20.9% equivalent to sea level and consecutively to simulated altitude (FiO2: 15.1% equivalent to 2500m above sea level) administered by an altitude Simulator ("Altitrainer, SMTEC"), simulated altitude (FiO2: 15.1%), with a facemask. | |
| Experimental: Order hypoxia-air The participant will be exposed to hypoxia (FiO2, 15.1% equivalent to 2500m above sea level), simulated altitude (FiO2: 15.1%), and consecutively to shamed hypoxia (FiO2, 20.9%) administered by an altitude simulator ("Altitrainer, SMTEC") with a facemask. |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | Inclusion Criteria: - Informed consent - PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis - PH class 1 (PAH) or 4 (CTEPH) - Stable condition, on the same medication for > 4 weeks - Patient live permanently at an altitude < 1000m asl. Exclusion Criteria: - Resting partial oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed) - Severe daytime hypercapnia (pCO2 > 6.5 kPa) - Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes. - Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation - Residence > 1000m above sea level - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability - Women who are pregnant or breast feeding |
Sonuç
Birincil Sonuç Ölçütleri
1. Cognitive Function test [2 hours]
