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Completed

NCT Number: NCT06489717

High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), SDB Assessed at HA (3200 m) vs LA (760 m)

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

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Key information

Conditions

High Altitude Pulmonary Hypertension Altitude Sickness Apnea Cardiovascular Diseases Dyssomnias Hypertension Hypertension, Pulmonary Hypoxia Lung Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Pulmonary edema of mountaineers Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aksay Medical Center

Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

SDB assessment

Other

SDB will be assessed by respiratory polygraphy according to clinical standards

Primary outcomes

  1. Mean nocturnal SpO2 during the first night at LA vs HA

    Time frame: night 1 at 760 m compared to 3200 m.

    Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m)

Secondary outcomes

  1. Mean nocturnal SpO2 during the sixth night at LA vs HA

    Time frame: night 6 at 760 m compared to 3200 m.

    Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m)

  2. Time spent with SpO2<90% at LA vs HA

    Time frame: 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)

  3. AHI at LA vs HA

    Time frame: 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)

  4. ODI at LA vs. HA

    Time frame: 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)

  5. Time spent with periodic breathing at LA vs. HA

    Time frame: 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)

  6. Heart rate variability at LA vs. HA

    Time frame: 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)

  7. ECG markers of repolarization at LA vs. HA

    Time frame: 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)

  8. pulse transit time drops at LA vs. HA

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Comparative Study of Sleep Disordered Breathing (SDB) in Patients With High Altitude Pulmonary Hypertension Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) 760 m

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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