Skip to main content
Clinical Trials/NCT06525857
NCT06525857
Recruiting
Not Applicable

Observing Physiological Changes in Patients With Long-term Oxygen Therapy Via Optical and Accelerometry Signals

Insel Gruppe AG, University Hospital Bern1 site in 1 country40 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Respiratory Disease
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
40
Locations
1
Primary Endpoint
SpO2 changes from before and during LTOT
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
January 31, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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
  • Willing and able to understand and provide signed informed consent

Exclusion Criteria

  • 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
  • Known participation in another human research project (ClinO/HRO) that may affect the objectives of this study.

Outcomes

Primary Outcomes

SpO2 changes from before and during LTOT

Time Frame: From 1 week before start of LTOT to 1 month after start of LTOT

Record SpO2 (%) to compare before and during LTOT

Respiratory rate changes from before and during LTOT

Time Frame: From 1 week before start of LTOT to 1 month after start of LTOT

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

Heart rate changes from before and during LTOT

Time Frame: From 1 week before start of LTOT to 1 month after start of LTOT

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

Study Sites (1)

Loading locations...

Similar Trials