Observing Physiological Changes in Patients With Long-term Oxygen Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Respiratory Disease
• Intervention / Treatment: Other: LTOT

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Sabina Guler, PD Dr. med.; Phone Number: +41 31 66 4 48 92; Email: sabina.guler@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital
    • Contact: Sabina Guler; Email: sabina.guler@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with a respiratory disease and newly prescribed LTOT

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate changes from before and during LTOT	Record heart rate (BPM) to compare before and during LTOT	From 1 week before start of LTOT to 1 month after start of LTOT
Respiratory rate changes from before and during LTOT	Record respiratory rate (breaths per minute) to compare before and during LTOT	From 1 week before start of LTOT to 1 month after start of LTOT
SpO2 changes from before and during LTOT	Record SpO2 (%) to compare before and during LTOT	From 1 week before start of LTOT to 1 month after start of LTOT

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Sabina Guler, PD Dr. med., Universitätsklinik für Pneumologie, Allergologie und klinische Immunologie, Inselspital Bern

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: STD0006706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No