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Chronic Obstructive Pulmonary DiseaseNCT05473780

Oxygen Therapy Remote Monitoring in COPD Patients.

An observational study of Chronic Obstructive Pulmonary Disease, run by Vivisol at 36 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background : Long-term oxygen therapy is prescribed for patients with severe COPD. The aim of oxygen therapy is to administer oxygen at a concentration level higher than that of ambient air, in order to treat or prevent the symptoms and manifestations of arterial hypoxemia; this therapy can be applied either in an… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
How many people
159 participants
Where
36 sitesFrance
Study dates
27 Jan 2023to 4 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Cohort of COPD patients who initiate long-term oxygen therapy.

Who may be able to join

  • COPD patients who require the initiation of a long term oxygen therapy.
  • Patient agreeing to use a connected watch and a TeleOx for the remote monitoring of their parameters and physical activity.
  • Non-smoker, ex-smoker, or patient agreeing to stop smoking.
  • Life expectancy greater than 6 months.
  • Signed informed consent form,
  • Subject affiliated to a health insurance system, or is a beneficiary.

Who cannot join

  • Patient initiated on oxygen therapy prior to the inclusion visit.
  • Patient with cognitive impairment.
  • Simultaneous participation in a health intervention research,
  • Vulnerable subjects.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

France36 sites

  • CHIAP

    Aix-en-Provence

  • CH Nord Ardèche

    Annonay, 07103

  • Cabinet privé

    Antibes

  • Hopital Privé de La Casamance

    Aubagne, 13400

  • Cabinet libéral

    Avignon

  • CH Avignon

    Avignon

  • CH Blois

    Blois

  • CH Bligny

    Briis-sous-Forges

  • CH Cannes

    Cannes

  • Hôpital Percy

    Clamart, 92140

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63000

  • CH Draguignan

    Draguignan, 83007

  • Cabinet libéral

    Foix

  • CH Emile Roux

    Le Puy-en-Velay, 43000

  • Cabinet libéral

    Le Puy-en-Velay

  • CH Libourne

    Libourne

  • Hôpital La Louvière

    Lille, 59800

  • Centre médical Parot

    Lyon

  • Hôpital Saint Joseph

    Marseille, 13285

  • Hôpital d'Instruction des Armées Laveran

    Marseille, 13384

  • AP-HM Hopital nord

    Marseille

  • CH de Martigues

    Martigues, 13698

  • GHSIF / CH Melun

    Melun, 77000

  • GHI Le Raincy

    Montfermeil

  • CHRU Nancy-Université de Lorraine

    Nancy, 54511

  • Polyclinique des fleurs

    Ollioules

  • CH Louis Giorgi d'Orange

    Orange, 84100

  • CH de Perpignan

    Perpignan, 66000

  • Pneumology practice

    Perpignan, 66000

  • CHU de Bordeaux

    Pessac, 33600

  • Cabinet libéral

    Poissy

  • CH St Nazaire

    Saint-Nazaire, 44600

  • MGEN

    Sainte-Feyre

  • cabinet du dr Radu Horia Bumbea

    Sallanches, 74600

  • Cabinet de Pneumologie

    Toulon

  • Clinique Pasteur

    Toulouse, 31000

Other trials in France

About this study

Official title: Observational Study: Oxygen Therapy Monitoring in COPD Patients Using Connected Devices.

Background : Long-term oxygen therapy is prescribed for patients with severe COPD. The aim of oxygen therapy is to administer oxygen at a concentration level higher than that of ambient air, in order to treat or prevent the symptoms and manifestations of arterial hypoxemia; this therapy can be applied either in an acute situation or as a long-term treatment, in cases of stabilized severe chronic hypoxemia.

Currently, pneumologists do not have the possibility, between 2 consultations spaced several months apart, to measure the patient's compliance with the treatment (adherence to oxygen therapy) nor the respect of the prescribed dosage (O2 flow and duration). In addition to the patient's adherence to the treatment, the specialist does not have the possibility to assess the patient's physical activity (walking ...).

Read more

This observational study is a e-health, prospective, multicenter study conducted in France under the control of pneumologists.

The main objective of this study is to evaluate the adherence to oxygen therapy in real life, and its evolution, in COPD patients justifying a long term oxygen therapy in stable state.

Read the detailed description

The observational study consists in collecting physiological data (cardiorespiratory and physical activity) and use of the oxygen therapy device in real life during the first months after the initiation of treatment.

For this purpose, two connected medical devices will be provided to each patient during 2 periods of 2 weeks (weeks 6 to 8 then weeks 12 to 14 after the initiation of oxygen therapy). The devices are: 1/ a connected watch that continuously measures vital parameters (heart rate and blood oxygen saturation), and physical activity parameters (no. of steps, distance, duration of effort), and 2/ a Teleox device that remotely monitors patients equipped with an oxygen source (it measures the oxygen flow rate requested by the patient, the duration of use of the oxygen source, and the breathing rate).

Study design: a cohort of 250 patients with COPD newly initiated a long term oxygen therapy will be enrolled in the study and follow-up over 6 months. Data will be collected by lung specialists and home health care provider teams at 2 months, 3.5 months and 6 months post-initiation of oxygen therapy.

Keywords
long term oxygen therapy, compliance, quality of life, exacerbation
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of compliance of long term oxygen therapy

    For each patient, the average daily duration of oxygen use (expressed as numbers of hours of oxygen use per day) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The duration of oxygen use is measured using the TeleOx medical device placed in each oxygen source (fixed and portable sources).

    Measured: 3.5 months

Secondary outcomes (8)

  1. Impact of long term oxygen therapy on heart rate

    For each patient, the average and maximum daily heart rate (expressed as beats/minute) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The heart rate is measured by the connected watch all along the day.

    Measured: Month 2, Month 3.5

  2. Impact of long term oxygen therapy on oxygen saturation in the blood (SpO2)

    For each patient, the average nightime and daytime SpO2 (expressed in %) will be calculated by period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The SpO2 is measured by the connected watch (automatically at night and manually in day).

    Measured: Month 2, Month 3.5

  3. Impact of long term oxygen therapy on the respiratory rate

    For each patient, the median, maximum, and 95th percentile daily respiratory rate (expressed in cycles/minute) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The respiratory rate is measured using the TeleOx medical device placed in each oxygen source (fixed and portable sources).

    Measured: Month 2, Month 3.5

  4. Impact of long term oxygen therapy on the physical activity in terms of duration of effort

    For each patient, the total duration of effort per day (expressed in hours) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The total duration of effort is measured by the connected watch.

    Measured: Month 2, Month 3.5

  5. Impact of long term oxygen therapy on the physical activity in terms of duration of number of steps

    For each patient, the total number of steps per day will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The number of steps is measured by the connected watch.

    Measured: Month 2, Month 3.5

  6. Impact of long term oxygen therapy on the health related quality of life of COPD patients

    The quality of life will be assessed using the COPD-specific health related quality of life questionnaire named VQ11.

    The questionnaire VQ11 comprises 11 items distributed across three components (functional: 3 items, psychological: 4 items, social: 4 items). The global score ranges from 11 to 55 points; higher scores mean a better quality of life.

    Measured: At oxygen therapy initiation (baseline), Month 2, Month 3.5

  7. Impact of long term oxygen therapy on the respiratory function

    The pulmonologist will assess the evolution of respiratory function according to good medical practice with the pulmonary functional tests. Based on the VEMS/CV value (expressed in %), the pulmonologist judges if the prescribed long term oxygen therapy is sufficient to normalize the respiratory function or if the treatment must be modified.

    Measured: At inclusion, Month 6

  8. Assessment of exacerbation

    The pulmonologist will assess the number of exacerbation that occured during the first 6-months of long term oxygen therapy.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start27 Jan 2023
  3. Primary completion15 Dec 2025
  4. Study completion4 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05473780
Sponsor's protocol ID
O2 Connect
Other IDs
IDRCB 2022-A00825-38
Status last verified
Mar 2026
First submitted
18 Jul 2022
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by Vivisol at 36 sites in France.

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 6 inclusion and 4 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assessment of compliance of long term oxygen therapy (time frame: 3.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05473780.

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 31 Mar 2026.

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