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Completed

NCT Number: NCT05089487

Nocturnal Oxygenation and Sleep-related Breathing Disorders During the First Night of a Stay at 2500m of High Altitude in Patients With Precapillary Pulmonary Hypertension

The impact of hypoxia at 2500m of high altitude on sleep in patients with precapillary pulmonary hypertension

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Key information

Conditions

High Altitude Pulmonary Hypertension Pulmonary edema of mountaineers Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent as documented by signature (Appendix Informed Consent Form)
  • PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion criteria

  • resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
  • exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
  • inability to follow the procedures of the study
  • other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Treatment and study plan

Nocturnal rest (sleep study)

Procedure

Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .

Primary outcomes

  1. Proportion of patients free of severe hypoxemia

    Time frame: 30 hours

    Proportion of patients free of severe hypoxemia (defined as oxygenation (SpO2)<80% for >30 min) without oxygen therapy during nocturnal rest at 2500 m vs. 490 m

Secondary outcomes

  1. Nocturnal oxygenation

    Time frame: 30 hours

    Difference in mean nocturnal oxygenation (SpO2) 2500 m of high altitude vs 490 m low altitude

  2. Oxygen desaturation index

    Time frame: 30 hours

    Difference in oxygen desaturation index sleeping at 2500 m high altitude vs 490 m low altitude

  3. Periodic breathing

    Time frame: 30 hours

    Difference in time spent with periodic breathing in patients sleeping at 2500 m of high altitude vs 490 m low altitude

  4. Nocturnal transcutaneous carbon dioxide tension

    Time frame: 30 hours

    Difference in nocturnal transcutaneous carbon dioxide tension in patients sleeping at 2500 m of high altitude vs 490 m low altitude

  5. Visual Analogue Scale

    Time frame: 30 hours

    Subjective sleep quality Visual Analogue Scale score 2500 m high altitude vs 490 m low altitude

  6. Time spent awake during the night

    Time frame: 30 hours

    Subjective time spent awake during the night high altitude vs 490 m low altitude

  7. Cerebral tissue deoxygenation

    Time frame: 30 hours

    Proportion of patients free of severe cerebral tissue deoxygenation (drop in cerebral tissue oxygen saturation >5%) without oxygen therapy during a night at 2500 vs. 490 m

  8. Cerebral tissue oxygen saturation awake

    Time frame: 30 hours

    Difference in cerebral tissue oxygen saturation awake in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude

  9. Cerebral tissue oxygen saturation during sleep without oxygen

    Time frame: 30 hours

    Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen

  10. Cerebral tissue oxygen saturation during sleep with oxygen

    Time frame: 30 hours

    Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude with supplemental oxygen

  11. Cerebral oxygen desaturation index without oxygen

    Time frame: 30 hours

    Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude

  12. Cerebral oxygen desaturation index with oxygen

    Time frame: 30 hours

    Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude under supplemental oxygen.

  13. Cerebral tissue oxygen saturation between different sleep stages

    Time frame: 30 hours

    Changes in the cerebral tissue oxygen saturation between different sleep stages at 2500 m compared to low altitude.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2021
Registry last updated
May 11, 2022

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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