Observing Physiological Changes in Patients With Long-term Oxygen Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

In this project, the investigators aim to assess changes of physiological parameters obtained non-invasively through PPG and accelerometry signals between before and during LTOT (long-term oxygen therapy) and investigate if those changes are different in patients with worsening frailty and/or improving quality of life.

For this, they will record optical (PPG) and accelerometry data via a datalogger on 40 patients undergoing LTOT and assess the PPG-derived physiological signals.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18-year-old, and

Chronic respiratory disease including a) chronic obstructive pulmonary disease, b) interstitial lung disease, c) pulmonary hypertension, d) bronchiectasis, and

Prescribed new LTOT due to a chronic respiratory disease with resting and/or exertional hypoxemia, and

Able to speak/read/understand German or French, and

Disqualifiers

Pregnant or lactating women, or

Inability to follow the procedures/instructions of the study (e.g. due to language, psychological disorders, dementia, etc.), or

Patients having a subordination link to the investigators, or

Patients with isolated nocturnal oxygen therapy or LTOT prescription for a heart disease, sleep associated breathing disorder, neuromuscular disease or lung cancer, or

Trial population

Patients with a respiratory disease and newly prescribed LTOT

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • LTOT

    Other intervention

    Patients with newly prescribed LTOT will be monitored for physiological changes

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Heart rate changes from before and during LTOT

Record heart rate (BPM) to compare before and during LTOT

Time frame
From 1 week before start of LTOT to 1 month after start of LTOT
2

Respiratory rate changes from before and during LTOT

Record respiratory rate (breaths per minute) to compare before and during LTOT

Time frame
From 1 week before start of LTOT to 1 month after start of LTOT
3

SpO2 changes from before and during LTOT

Record SpO2 (%) to compare before and during LTOT

Time frame
From 1 week before start of LTOT to 1 month after start of LTOT

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.