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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 ...). 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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHIAP
Aix-en-Provence, France
CH Nord Ardèche
Annonay, France
Cabinet privé
Antibes, France
Hopital Privé de La Casamance
Aubagne, 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, France
Start Date
January 27, 2023
Primary Completion Date
December 15, 2025
Completion Date
January 15, 2026
Last Updated
December 16, 2025
161
ACTUAL participants
Lead Sponsor
Vivisol
Collaborators
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
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