Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen

Chronic Obstructive Pulmonary Disease Clinical Trial

— MONOX  

Official title:

Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04204031
• Other study ID #: 2019-01954
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2019
• Source: Haute Ecole de Santé Vaud
• Contact: Olivier Contal, PhD
• Phone: +41213168122
• Email: olivier.contal[@]hesav.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to measure the actual use time in patients receiving supplemental oxygen using a new easy-to-use electronic remote monitoring device (TeleOx™)

Description:

The first phase of the study is observational. Oxygen use time of patients with chronic respiratory failure under long term oxygen therapy will be objectively measured using a electronic remote monitoring device (TeleOx™) over 15 days. The actual use time will be compared to their oxygen prescription.

Participants whose actual time of use will be less than prescribed will be offered an intervention which will consist of a presentation of the adherence record. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible. Only participants with an actual time of use less than prescribed will be offered this intervention and will continue the monitoring over a period of 15 additional days.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Long term oxygeno-therapy patients in stable condition without pulmonary exacerbation in the month before inclusion

• Oxygen prescription for at least 15 hours/day

Exclusion Criteria:

• under 18 years old

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Chronic Respiratory Failure With Hypoxia
• Hypoxia
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Behavioral:
• Presentation of the adherence record
Adherence record will be presented to participants with an actual time of use less than prescribed. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible.

Locations

Country	Name	City	State
Switzerland	Haute Ecole de Santé Vaud (HESAV)	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
Haute Ecole de Santé Vaud	Ligue Pulmonaire Genevoise, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen use time	Average oxygen use time (hours/day) measured with a TeleOx device	15 days