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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

Primary Purpose

High Altitude Pulmonary Hypertension, Sleep

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Nocturnal rest (sleep study)
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for High Altitude Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High altitude 2500 m above sea level

Low altitude 470 m above sea level

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients free of severe hypoxemia
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 Outcome Measures

Nocturnal oxygenation
Difference in mean nocturnal oxygenation (SpO2) 2500 m of high altitude vs 490 m low altitude
Oxygen desaturation index
Difference in oxygen desaturation index sleeping at 2500 m high altitude vs 490 m low altitude
Periodic breathing
Difference in time spent with periodic breathing in patients sleeping at 2500 m of high altitude vs 490 m low altitude
Nocturnal transcutaneous carbon dioxide tension
Difference in nocturnal transcutaneous carbon dioxide tension in patients sleeping at 2500 m of high altitude vs 490 m low altitude
Visual Analogue Scale
Subjective sleep quality Visual Analogue Scale score 2500 m high altitude vs 490 m low altitude
Time spent awake during the night
Subjective time spent awake during the night high altitude vs 490 m low altitude
Cerebral tissue deoxygenation
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
Cerebral tissue oxygen saturation awake
Difference in cerebral tissue oxygen saturation awake in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude
Cerebral tissue oxygen saturation during sleep without oxygen
Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen
Cerebral tissue oxygen saturation during sleep with oxygen
Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude with supplemental oxygen
Cerebral oxygen desaturation index without oxygen
Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude
Cerebral oxygen desaturation index with oxygen
Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude under supplemental oxygen.
Cerebral tissue oxygen saturation between different sleep stages
Changes in the cerebral tissue oxygen saturation between different sleep stages at 2500 m compared to low altitude.

Full Information

First Posted
October 14, 2021
Last Updated
May 10, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05089487
Brief Title
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
Official Title
The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Pulmonary Hypertension, Sleep

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High altitude 2500 m above sea level
Arm Type
Experimental
Arm Title
Low altitude 470 m above sea level
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Nocturnal rest (sleep study)
Intervention Description
Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .
Primary Outcome Measure Information:
Title
Proportion of patients free of severe hypoxemia
Description
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
Time Frame
30 hours
Secondary Outcome Measure Information:
Title
Nocturnal oxygenation
Description
Difference in mean nocturnal oxygenation (SpO2) 2500 m of high altitude vs 490 m low altitude
Time Frame
30 hours
Title
Oxygen desaturation index
Description
Difference in oxygen desaturation index sleeping at 2500 m high altitude vs 490 m low altitude
Time Frame
30 hours
Title
Periodic breathing
Description
Difference in time spent with periodic breathing in patients sleeping at 2500 m of high altitude vs 490 m low altitude
Time Frame
30 hours
Title
Nocturnal transcutaneous carbon dioxide tension
Description
Difference in nocturnal transcutaneous carbon dioxide tension in patients sleeping at 2500 m of high altitude vs 490 m low altitude
Time Frame
30 hours
Title
Visual Analogue Scale
Description
Subjective sleep quality Visual Analogue Scale score 2500 m high altitude vs 490 m low altitude
Time Frame
30 hours
Title
Time spent awake during the night
Description
Subjective time spent awake during the night high altitude vs 490 m low altitude
Time Frame
30 hours
Title
Cerebral tissue deoxygenation
Description
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
Time Frame
30 hours
Title
Cerebral tissue oxygen saturation awake
Description
Difference in cerebral tissue oxygen saturation awake in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude
Time Frame
30 hours
Title
Cerebral tissue oxygen saturation during sleep without oxygen
Description
Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen
Time Frame
30 hours
Title
Cerebral tissue oxygen saturation during sleep with oxygen
Description
Difference in cerebral tissue oxygen saturation during sleep in patients with precapillary pulmonary hypertension at 2500m of high altitude with supplemental oxygen
Time Frame
30 hours
Title
Cerebral oxygen desaturation index without oxygen
Description
Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude without supplemental oxygen vs. low altitude
Time Frame
30 hours
Title
Cerebral oxygen desaturation index with oxygen
Description
Difference in the cerebral oxygen desaturation index in patients with precapillary pulmonary hypertension at 2500m of high altitude under supplemental oxygen.
Time Frame
30 hours
Title
Cerebral tissue oxygen saturation between different sleep stages
Description
Changes in the cerebral tissue oxygen saturation between different sleep stages at 2500 m compared to low altitude.
Time Frame
30 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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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

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