Observing Physiological Changes in Patients With Long-term Oxygen Therapy

NCT06525857 | Recruiting

• 1 other identifier: STD0006706
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Respiratory Disease

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

LTOT OTHER

Patients with newly prescribed LTOT will be monitored for physiological changes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a respiratory disease and newly prescribed LTOT

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Study Officials

• Sabina Guler, PD Dr. med.

  Universitätsklinik für Pneumologie, Allergologie und klinische Immunologie, Inselspital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabina Guler, PD Dr. med.

CONTACT

+41 31 66 4 48 92; sabina.guler@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 29, 2024
• Study Start: June 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: January 31, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)