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Active, not recruitingNCT07024914Updated Jun 17, 2025

Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During STST in COPD Patients

An interventional study of Oxygen and medical air in Chronic Obstructive Pulmonary Disease (COPD), sponsored by George Papanicolaou Hospital. Active, not recruiting at 1 site in Greece. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by George Papanicolaou Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
  • Registered 5 years 8 months after the study started (first participant enrolled Sep 2019, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Sex
All
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Study summary

It is a randomised, single-blind trial of the effect of acute oxygen supplementation on cerebral oxygenation during the 30 sec Sit-To-Stand Test (STST) in chronic obstructive pulmonary disease patients, without resting hypoxemia. After an initial clinical assessment, patients preform the 30sec STST under near-infrared spectroscopy, a non invasive technique which assesses cerebral oxygenation at the prefrontal lobe. Measurements are performed twice, under oxygen supplementation or medical air, in a random order, and the patients are be blinded to the treatment (oxygen or medical air) given.

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Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
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In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 25 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

George Papanicolaou Hospital is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. clinical diagnosis of COPD, based on smoking history of at least 100 cigarettes and post bronchodilation forced expiratory volume (FEV1) to forced vital capacity (FVC) ratio \<0.7, and 2) resting arterial oxygen partial pressure >60 mmHg, according to recent (within a week) arterial blood gases assessment.

Exclusion criteria

Exclusion Criteria:

  1. recent COPD exacerbation (as indicated by deterioration of respiratory symptoms, hospital admission and/or change in medication within the previous month), 2) history of specific balance problems (i.e., diagnosed neurological or vestibular disorder), 3) spinal surgery, and 4) lower limb musculoskeletal problems (i.e., surgery, injury or pathology at hip, knee, ankle or foot)

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
25 participants (estimated)

Study arms

  • Active comparator
    Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD

    Oxygen supplementation via nasal cannula at a rate of 3 lit/min

    Drug: Oxygen

  • Sham comparator
    Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD

    Medical air supplementation via nasal cannula at a rate of 3 lit/min

    Drug: medical air

Interventions

  • DrugOxygen

    Oxygen supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia

  • Drugmedical air

    Medical Air supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia

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What researchers measure

Primary outcomes

  1. cerebral oxygenation at the prefrontal lobe

    Near infrared spectroscopy will be utilised to assess cerebral oxygenation, by measuring oxygenated hemoglobin (O2Hb) at the prefrontal lobe, in COPD patients

    Time frame: For 2 and a half minutes (one minute of rest, 30 seconds during Sit-To-Stand Test and one minute of recovery after the test)

Secondary outcomes

  1. Number of repetitions during Sit-To-Stand Test

    The number of repetitions (fully standing and sitting) during the Sit-To-Stand Test

    Time frame: From the initiation till the end of the Sit-To-Stand Test, that is 30 seconds.

  2. Severity of dyspnea

    Rate of dyspnea according to dyspnea Borg scale (0-10)

    Time frame: At the end of the 30 second Sit-To-Stand Test

  3. Severity of fatigue

    Score according to Rate of Perceived Exertion

    Time frame: At the end of the 30 seconds Sit-To-Stand Test

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Study locations

1 site
  • Papanikolaou General Hospital
    Thessaloniki, 57010, Greece
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References and documents

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07024914
Lead sponsor
George Papanicolaou Hospital
Responsible party
Afroditi Boutou (Consultant in Pulmonary Medicine, George Papanicolaou Hospital) — Principal investigator
First posted
Jun 17, 2025
Start date
Sep 18, 2019
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 17, 2025

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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