Oxygen Therapy Remote Monitoring in COPD Patients.

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473780
• Other study ID #: O2 Connect
• Secondary ID: IDRCB 2022-A0082
• Status: Recruiting
• Start date: January 27, 2023
• Est. completion date: January 27, 2025

Study information

• Verified date: May 2024
• Source: Vivisol
• Contact: Anne-Laure Sérandour
• Phone: +33 2 99 12 19 62
• Email: al.serandour[@]slbpharma.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 27, 2025
• Est. primary completion date: January 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	CHIAP	Aix-en-Provence
France	Cabinet privé	Antibes
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	Cabinet libéral	Foix
France	Cabinet libéral	Le Puy-en-Velay
France	CH Libourne	Libourne
France	Hôpital La Louvière	Lille
France	Centre médical Parot	Lyon
France	AP-HM Hopital nord	Marseille
France	Hôpital d'Instruction des Armées Laveran	Marseille
France	Hôpital Saint Joseph	Marseille
France	GHI Le Raincy	Montfermeil
France	CHRU Nancy-Université de Lorraine	Nancy
France	Polyclinique des fleurs	Ollioules
France	CH de Perpignan	Perpignan
France	Pneumology practice	Perpignan
France	CHU de Bordeaux	Pessac
France	Cabinet libéral	Poissy
France	MGEN	Sainte-Feyre

Sponsors (2)

Lead Sponsor	Collaborator
Vivisol	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Month 2, Month 3.5
Secondary	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).	Month 2, Month 3.5
Secondary	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).	Month 2, Month 3.5
Secondary	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.	Month 2, Month 3.5
Secondary	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.	Month 2, Month 3.5
Secondary	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.	At oxygen therapy initiation (baseline), Month 2, Month 3.5
Secondary	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.	At inclusion, Month 6
Secondary	Assessment of exacerbation	The pulmonologist will assess the number of exacerbation that occured during the first 6-months of long term oxygen therapy.	Month 6