Oxygen Therapy Remote Monitoring in COPD Patients.
Observational Study: Oxygen Therapy Monitoring in COPD Patients Using Connected Devices.
2 other identifiers
observational
159
1 country
36
Brief 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 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 ...). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2023
Typical duration for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedStudy Start
First participant enrolled
January 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2026
CompletedMarch 31, 2026
March 1, 2026
2.9 years
July 18, 2022
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
3.5 months
Secondary Outcomes (8)
Impact of long term oxygen therapy on heart rate
Month 2, Month 3.5
Impact of long term oxygen therapy on oxygen saturation in the blood (SpO2)
Month 2, Month 3.5
Impact of long term oxygen therapy on the respiratory rate
Month 2, Month 3.5
Impact of long term oxygen therapy on the physical activity in terms of duration of effort
Month 2, Month 3.5
Impact of long term oxygen therapy on the physical activity in terms of duration of number of steps
Month 2, Month 3.5
- +3 more secondary outcomes
Eligibility Criteria
Cohort of COPD patients who initiate long-term oxygen therapy.
You may qualify if:
- 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.
You may not qualify if:
- Patient with cognitive impairment.
- Simultaneous participation in a health intervention research,
- Vulnerable subjects.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vivisollead
- Slb Pharmacollaborator
Study Sites (36)
CHIAP
Aix-en-Provence, France
CH Nord Ardèche
Annonay, 07103, France
Cabinet privé
Antibes, France
Hopital Privé de La Casamance
Aubagne, 13400, France
Cabinet libéral
Avignon, France
CH Avignon
Avignon, France
CH Blois
Blois, France
CH Bligny
Briis-sous-Forges, France
CH Cannes
Cannes, France
Hôpital Percy
Clamart, 92140, France
CHU Gabriel Montpied
Clermont-Ferrand, 63000, France
CH Draguignan
Draguignan, 83007, France
Cabinet libéral
Foix, France
CH Emile Roux
Le Puy-en-Velay, 43000, France
Cabinet libéral
Le Puy-en-Velay, France
CH Libourne
Libourne, France
Hôpital La Louvière
Lille, 59800, France
Centre médical Parot
Lyon, France
Hôpital Saint Joseph
Marseille, 13285, France
Hôpital d'Instruction des Armées Laveran
Marseille, 13384, France
AP-HM Hopital nord
Marseille, France
CH de Martigues
Martigues, 13698, France
GHSIF / CH Melun
Melun, 77000, France
GHI Le Raincy
Montfermeil, France
CHRU Nancy-Université de Lorraine
Nancy, 54511, France
Polyclinique des fleurs
Ollioules, France
CH Louis Giorgi d'Orange
Orange, 84100, France
CH de Perpignan
Perpignan, 66000, France
Pneumology practice
Perpignan, 66000, France
CHU de Bordeaux
Pessac, 33600, France
Cabinet libéral
Poissy, France
CH St Nazaire
Saint-Nazaire, 44600, France
MGEN
Sainte-Feyre, France
cabinet du dr Radu Horia Bumbea
Sallanches, 74600, France
Cabinet de Pneumologie
Toulon, France
Clinique Pasteur
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ari CHAOUAT, Pr
CHRU Nancy-Université de Lorraine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 26, 2022
Study Start
January 27, 2023
Primary Completion
December 15, 2025
Study Completion
February 4, 2026
Last Updated
March 31, 2026
Record last verified: 2026-03