Chronic Obstructive Pulmonary Disease (COPD)NCT07024914
Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During STST in COPD Patients
A study testing Oxygen and medical air in people with Chronic Obstructive Pulmonary Disease (COPD), run by George Papanicolaou Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Oxygen and medical air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteGreece
- Study dates
- 18 Sep 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During 30 Sec STST in Chronic Obstructivepulmonary Disease Patients, Without Resting Hypoxemia
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.
- Being tested
- Oxygen, medical air
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Oxygen supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia
medical airDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD | Active comparator | Oxygen supplementation via nasal cannula at a rate of 3 lit/min Receives: Drug: Oxygen |
| Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD | Sham comparator | Medical air supplementation via nasal cannula at a rate of 3 lit/min Receives: Drug: medical air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (3)
Number of repetitions during Sit-To-Stand Test
The number of repetitions (fully standing and sitting) during the Sit-To-Stand Test
Measured: From the initiation till the end of the Sit-To-Stand Test, that is 30 seconds.
Severity of dyspnea
Rate of dyspnea according to dyspnea Borg scale (0-10)
Measured: At the end of the 30 second Sit-To-Stand Test
Severity of fatigue
Score according to Rate of Perceived Exertion
Measured: At the end of the 30 seconds Sit-To-Stand Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start18 Sep 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afroditi Boutou, George Papanicolaou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024914
- Sponsor's protocol ID
- GeorgePH39/16-01-2019
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During 30 Sec STST in Chronic Obstructivepulmonary Disease Patients, Without Resting Hypoxemia
- ClinicalTrials.gov ID
- NCT07024914
- Acronym / sponsor ID
- GeorgePH39/16-01-2019
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD | Active comparator | Drug: OxygenOxygen supplementation via nasal cannula at a rate of 3 lit/min |
| Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD | Sham comparator | Drug: medical airMedical air supplementation via nasal cannula at a rate of 3 lit/min |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenOxygen supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia | Drug | Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD |
| medical airMedical Air supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia | Drug | Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD |
Primary outcome
cerebral oxygenation at the prefrontal lobe
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)
Near infrared spectroscopy will be utilised to assess cerebral oxygenation, by measuring oxygenated hemoglobin (O2Hb) at the prefrontal lobe, in COPD patients
3 secondary outcomes
Number of repetitions during Sit-To-Stand Test
Time frame: From the initiation till the end of the Sit-To-Stand Test, that is 30 seconds.
Severity of dyspnea
Time frame: At the end of the 30 second Sit-To-Stand Test
Severity of fatigue
Time frame: At the end of the 30 seconds Sit-To-Stand Test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen and medical air in people with Chronic Obstructive Pulmonary Disease (COPD), run by George Papanicolaou Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral oxygenation at the prefrontal lobe (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.