Observing changes in patients on long-term oxygen therapy
Observing Physiological Changes in Patients With Long-term Oxygen Therapy Via Optical and Accelerometry Signals
This study is testing how long-term oxygen therapy affects the health and daily activity levels of patients with chronic respiratory diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06525857 on ClinicalTrials.gov |
What this trial studies
This project aims to assess non-invasive physiological changes in patients undergoing long-term oxygen therapy (LTOT) for chronic respiratory diseases. Investigators will collect data using photoplethysmography (PPG) and accelerometry signals from 40 patients to evaluate how these parameters change before and during LTOT. The study will also explore differences in these changes among patients experiencing worsening frailty or improving quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic respiratory diseases who have been prescribed new LTOT due to hypoxemia.
Not a fit: Patients who are pregnant, have psychological disorders, or are receiving LTOT for conditions other than chronic respiratory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the physiological effects of LTOT, potentially leading to improved management of chronic respiratory diseases.
How similar studies have performed: While this approach is observational and may not have been extensively tested in this specific context, similar studies have shown promise in understanding physiological changes in patients with chronic respiratory conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bern
- Inselspital, Bern University Hospital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Sabina Guler, PD Dr. med. — Universitätsklinik für Pneumologie, Allergologie und klinische Immunologie, Inselspital Bern
- Study coordinator: Sabina Guler, PD Dr. med.
- Email: sabina.guler@insel.ch
- Phone: +41 31 66 4 48 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.