Induced sputum is a non-invasive method to collect samples from the airways. It involves inhaling a saline mist to loosen mucus, which is then coughed up. The samples are used to study markers of lung disease. In some people, this procedure yields only small amounts of sample. This study looks at whether adding a vibroacoustic device during sputum induction can increase the amount of sputum collected in patients with chronic obstructive pulmonary disease (COPD). The device applies gentle sound-based vibrations to the chest to help move mucus in the airways. Each participant undergoes two sputum collection procedures on separate days: one with and one without the device. The order is assigned at random. The main comparison is the amount of sputum obtained with versus without the device in the same person. The study also assesses how well the procedure is tolerated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
A CE-marked vibroacoustic device is applied to the chest wall during sputum induction. It generates frequency-modulated acoustic waves transmitted through the chest to help mobilize airway secretions.
Sputum induction performed according to ATS/ERS recommendations: inhalation of nebulized saline to stimulate airway secretions, followed by directed coughing to expectorate sputum. Performed without the vibroacoustic device.
Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Department of Clinical Airway Research
Hanover, Lower Saxony, Germany
RECRUITINGWithin-subject difference in weight of selected sputum plugs (with vs. without device)
Weight in grams of selected sputum plugs obtained by induced sputum collection, determined by gravimetry. The primary analysis is the within-subject difference in sputum plug weight between the procedure performed with adjunctive use of the vibroacoustic device and the procedure performed without the device.
Time frame: At each of the two sputum induction visits (Visit 1 and Visit 2, approximately 14 to 21 days apart)
Within-subject difference in procedural discomfort rating (with vs. without device)
Overall procedural discomfort assessed immediately after each sputum induction procedure using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no discomfort) to 10 (worst imaginable discomfort); higher scores indicate greater discomfort (worse outcome). The within-subject difference in scores between the device and non-device conditions is used to assess device-related procedural burden.
Time frame: Immediately after each sputum induction procedure at Visit 1 and Visit 2
Proportion of participants willing to undergo the device-assisted procedure again
Device acceptability, measured as the proportion of participants who report they would be willing to undergo the device-assisted sputum induction procedure again (yes/no), recorded at the visit at which the device was applied.
Time frame: At the device-assisted procedure (Day 1 or Day 14, up to Day 21)
Proportion of participants completing all device-assisted inhalation periods
Device completion rate, defined as the proportion of participants who complete all device-assisted inhalation periods without premature discontinuation of the device and without reduction to single-emitter application.
Time frame: At the device-assisted procedure (Day 1 or Day 14, up to Day 21)
Incidence, nature, and severity of procedure-related adverse events
Adverse events recorded at each visit, including onset, duration, intensity, and causal relationship to study procedures. The crossover design allows comparison of adverse event profiles between the device and non-device conditions.
Time frame: From Visit 1 through end of study (up to approximately 21 days)
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