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

NCT06489717 | Completed

• 1 other identifier: HAPH_HAvsLA_SDB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

High Altitude Pulmonary Hypertension

Keywords

Pulmonary Hypertension; Hypoxia; High Altitude; Sleep disordered breathing

Outcome Measures

Primary Outcomes (1)

• Mean nocturnal SpO2 during the first night at LA vs HA

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

  night 1 at 760 m compared to 3200 m.

Secondary Outcomes (8)

• Mean nocturnal SpO2 during the sixth night at LA vs HA

  night 6 at 760 m compared to 3200 m.

• Time spent with SpO2<90% at LA vs HA

  night 1 and night 6 at 760 m compared to 3200 m.

• AHI at LA vs HA

  night 1 and night 6 at 760 m compared to 3200 m.

• ODI at LA vs. HA

  night 1 and night 6 at 760 m compared to 3200 m.

• Time spent with periodic breathing at LA vs. HA

  night 1 and night 6 at 760 m compared to 3200 m.

Study Arms (1)

Assessments at 3200 m and 760 m, respectively

EXPERIMENTAL

Participants will have a SDB assessment near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days

Other: SDB assessment

Interventions

SDB assessment OTHER

SDB will be assessed by respiratory polygraphy according to clinical standards

Assessments at 3200 m and 760 m, respectively

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Aksay Medical Center

Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary edema of mountaineers; Hypertension, Pulmonary; Hypoxia; Altitude Sickness; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Talant M Sooronbaev, Prof. Dr.

  National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

  PRINCIPAL INVESTIGATOR

• Silvia Ulrich, Prof. Dr.

  University Hospital Zurich, Department of Pulmonology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each highlander with HAPH will be assessed for SDB at 3200 m and at 760 m according to a prospective study design

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: July 2, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

KY (1)