High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), SDB Assessed at HA (3200 m) vs LA (760 m)
- Conditions
- High Altitude Pulmonary Hypertension
- Interventions
- Other: SDB assessment
- Registration Number
- NCT06489717
- Lead Sponsor
- University of Zurich
- Brief Summary
To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live \>2500m on sleep disordered breathing
- Detailed Description
This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA \>30 mmHg who permanently live at HA \>2500 m will have nocturnal respiratory sleep studies near their living altitude in Aksay at 3200 m and on night 1 and 6 at 760m after relocation.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Permanently living >2500 m
- HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
- Written informed consent
- Highlanders who cannot follow the study investigations,
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, heavy smoking >20 cigarettes/day or >20 pack-years.
- Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
- Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Assessments at 3200 m and 760 m, respectively SDB assessment Participants will have a SDB assessment near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days
- Primary Outcome Measures
Name Time Method Mean nocturnal SpO2 during the first night at LA vs HA night 1 at 760 m compared to 3200 m. Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m)
- Secondary Outcome Measures
Name Time Method AHI at LA vs HA night 1 and night 6 at 760 m compared to 3200 m. Change in apnea-hypopnea index (AHI) between LA (760 m) vs HA (3200 m)
Time spent with periodic breathing at LA vs. HA night 1 and night 6 at 760 m compared to 3200 m. Change in time spent with periodic breathingbetween LA (760 m) vs HA (3200 m)
Heart rate variability at LA vs. HA night 1 and night 6 at 760 m compared to 3200 m. Change in heart rate variability between LA (760 m) vs HA (3200 m)
pulse transit time drops at LA vs. HA night 1 and night 6 at 760 m compared to 3200 m. Change in pulse transit time drops between LA (760 m) vs HA (3200 m)
Time spent with SpO2<90% at LA vs HA night 1 and night 6 at 760 m compared to 3200 m. Change in time spent with SpO2\<90% between LA (760 m) vs HA (3200 m)
Mean nocturnal SpO2 during the sixth night at LA vs HA night 6 at 760 m compared to 3200 m. Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m)
ODI at LA vs. HA night 1 and night 6 at 760 m compared to 3200 m. Change in oxygen desaturation index (ODI) between LA (760 m) vs HA (3200 m)
ECG markers of repolarization at LA vs. HA night 1 and night 6 at 760 m compared to 3200 m. Change in electrocardiogram (ECG) markers of repolarization (QT time) between LA (760 m) vs HA (3200 m)
Trial Locations
- Locations (1)
Aksay Medical Center
🇰🇬Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan