ClinicalTrials.gg
RecruitingNCT07777445Updated Sep 9, 2026

Exercise Performance on Ambient Air vs. Low-Flow Liquid Oxygen Therapy in Pulmonary Vascular Disease (PVD)

An interventional study of 6-minute walk distance (6MWD) test on ambient conditions and 6-minute walk distance (6MWD) test with supplemental oxygen (LOX) in Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH), sponsored by Silvia Ulrich Somaini. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Silvia Ulrich Somaini · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators aim to study the effect of liquid oxygen therapy (4l/min, nasal) )in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).

Read the detailed description

Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without nasal liquid oxygen therapy (LOX) approximately 4l/min via nasal cannula according to a randomized cross-over design.

The trial aims to test that the 6MWD with LOX is inferior to a 6MWD in the same participant under ambient air.

02

Conditions studied

  • Pulmonary Vascular Disease
  • Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
  • Pulmonary Arterial Hypertension (PAH)

Keywords

  • Pulmonary Hypertension
  • Supplemental Oxygen Therapy
  • Pulmonary Arterial Hypertension
  • Chronic Thromboembolic Pulmonary Hypertension
  • 6-Minute Walk Distance
03

In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Silvia Ulrich Somaini is the lead sponsor of 17 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Minimum 18 years of age
  • Written
  • Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH), (COPD) with emphysema, COPD without emphysema, or interstitial lung disease
  • Former desaturation under exercise defined as SpO2-decrease >3%
  • Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion criteria

Exclusion Criteria:

  • - Severe hypoxemia needing supplemental oxygen therapy defined as PaO2 \< 6.9 kPa
  • Inability or to undergo the investigated intervention
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, walk disability etc.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Ambient air

    Patient will be assessed at University Hospital Zurich

    Other: 6-minute walk distance (6MWD) test on ambient conditions

  • Active comparator
    Liquid oxygen therapy via nasal canula

    Supplemental Liquid Oxygen Therapy (LOX) at approximately 4l/min will be provided via nasal canula from a small oxygen tank at University Hospital Zurich to perform clinical assessments.

    Other: 6-minute walk distance (6MWD) test with supplemental oxygen (LOX)

Interventions

  • Other6-minute walk distance (6MWD) test on ambient conditions

    6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards

  • Other6-minute walk distance (6MWD) test with supplemental oxygen (LOX)

    6-minute walk test(6MWT) test will be performed according to clinical standards with supplemental liquid oxygen therapy (LOX, approximately 4l/min, nasal)

06

What researchers measure

Primary outcomes

  1. 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air

    Change in 6MWD in meter between supplemental liquid oxygen therapy (LOX) via nasal cannula vs. ambient air

    Time frame: Distance will be measured at the end of 6 minutes from the 6MWT

Secondary outcomes

  1. SpO2 at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air

    Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with LOX approximately 4l /min vs. ambient air

    Time frame: 6 minutes

  2. Heart rate at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air

    Change of heart rate (bpm) at rest and at peak 6MWD with LOX vs. ambient air

    Time frame: 6 minutes

  3. Borg dyspnea at rest and peak 6MWT with supplemental liquid oxygen therapy (LOX) s. ambient air

    Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with LOX vs. ambient air

    Time frame: 6 minutes

  4. Borg leg fatigue scale at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air

    Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWT with LOX vs. ambient air

    Time frame: 6 minutes

  5. Blood pressure at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air

    Change of blood pressure (mmHg) at rest and at peak 6MWD with LOX vs. ambient air

    Time frame: 6 minutes

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Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data will be provided upon request and based on a clear intention reviewed by an ethical review board

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07777445
Lead sponsor
Silvia Ulrich Somaini
Responsible party
Silvia Ulrich Somaini (Prof. Dr. med., University of Zurich) — Sponsor-investigator
First posted
Aug 20, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Silvia Ulrich, Prof. Dr. med.
Contact
silvia.ulrich@usz.ch
+41442552220
Mona Lichtblau, PD. Dr. med.
Contact
mona.lichtblau@usz.ch
+41442552220
Silvia Ulrich, Prof. Dr. med.
principal investigator · University Hospital Zurich, Department of Pulmonology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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