Remote monitoring of oxygen therapy in COPD patients
Observational Study: Oxygen Therapy Monitoring in COPD Patients Using Connected Devices.
This study is testing how well remote monitoring can help people with severe COPD stick to their oxygen therapy and stay active over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vivisol Academic / other |
| Locations | 24 sites (Aix-en-Provence and 23 other locations) |
| Trial ID | NCT05473780 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the compliance and effectiveness of long-term oxygen therapy in patients with severe Chronic Obstructive Pulmonary Disease (COPD) through remote monitoring. Patients will use connected devices, including a watch that tracks vital signs and physical activity, and a Teleox device that monitors oxygen usage. Data will be collected over six months from a cohort of 250 newly initiated oxygen therapy patients, allowing specialists to assess treatment adherence and physical activity levels. The study is conducted in multiple centers across France under the supervision of lung specialists.
Who should consider this trial
Good fit: Ideal candidates include COPD patients who are newly prescribed long-term oxygen therapy and are willing to use connected monitoring devices.
Not a fit: Patients who have previously initiated oxygen therapy or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of COPD patients by improving adherence to oxygen therapy and overall quality of life.
How similar studies have performed: While the approach of remote monitoring in COPD patients is gaining traction, this specific methodology is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patient initiated on oxygen therapy prior to the inclusion visit. * Patient with cognitive impairment. * Simultaneous participation in a health intervention research, * Vulnerable subjects.
Where this trial is running
Aix-en-Provence and 23 other locations
- Chiap — Aix-en-Provence, France (Recruiting)
- Cabinet privé — Antibes, France (Not_yet_recruiting)
- Cabinet libéral — Avignon, France (Not_yet_recruiting)
- CH Avignon — Avignon, France (Not_yet_recruiting)
- CH Blois — Blois, France (Not_yet_recruiting)
- CH Bligny — Briis-sous-Forges, France (Not_yet_recruiting)
- CH Cannes — Cannes, France (Not_yet_recruiting)
- Hôpital Percy — Clamart, France (Not_yet_recruiting)
- Cabinet libéral — Foix, France (Not_yet_recruiting)
- Cabinet libéral — Le Puy-en-Velay, France (Not_yet_recruiting)
- CH Libourne — Libourne, France (Not_yet_recruiting)
- Hôpital La Louvière — Lille, France (Not_yet_recruiting)
- Centre médical Parot — Lyon, France (Not_yet_recruiting)
- Hôpital Saint Joseph — Marseille, France (Not_yet_recruiting)
- Hôpital d'Instruction des Armées Laveran — Marseille, France (Not_yet_recruiting)
- AP-HM Hopital nord — Marseille, France (Not_yet_recruiting)
- GHI Le Raincy — Montfermeil, France (Not_yet_recruiting)
- CHRU Nancy-Université de Lorraine — Nancy, France (Not_yet_recruiting)
- Polyclinique des fleurs — Ollioules, France (Not_yet_recruiting)
- CH de Perpignan — Perpignan, France (Not_yet_recruiting)
- Pneumology practice — Perpignan, France (Not_yet_recruiting)
- CHU de Bordeaux — Pessac, France (Not_yet_recruiting)
- Cabinet libéral — Poissy, France (Not_yet_recruiting)
- Mgen — Sainte-Feyre, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Ari CHAOUAT, Pr — CHRU Nancy-Université de Lorraine
- Study coordinator: Anne-Laure Sérandour
- Email: al.serandour@slbpharma.com
- Phone: +33 2 99 12 19 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.