Non-invasive Positive Expiratory Pressure Mask (PEEP-Mask) for Tracheobronchomalacia Associated Cough

PROSPECTIVE:

Twenty subjects with chronic cough and TBM diagnosed by bronchoscopy or computed tomography (CT) scan will be recruited to enroll 12 participants. Comorbid conditions that can cause chronic cough, such as asthma, COPD, and GERD, must be treated if present, for subjects to qualify. At the pre-baseline visit (V0), after obtaining verbal informed consent, each subject will complete validated cough questionnaires to quantify their cough severity and cough-related QOL at baseline. The baseline visit (V1) will occur in-person approximately two weeks later, after a run-in period to minimize observation bias related to the cough questionnaires. Written consent will be performed at this visit. At V1, the cough questionnaires will be repeated and subjects' airway resistance and reactance will be measured with impulse oscillometry (IOS). A study physician will perform a physical exam and determine eligibility. Eligible subjects will then be given the nPEP device by the study team and instructed on its use. Approximately four to six weeks after device delivery, at the follow-up visit (V3), cough questionnaires and IOS will be repeated and they will be asked for feedback regarding device design and user experience. Subjects may then be entered into a cohort for up to six additional months, during which there will be no study visits or procedures, but subjects may be contacted by investigators for additional narrative feedback on the device and its use.

Study subjects will be given an nPEP device to use for four to six weeks. During this time participants will be asked to remain on their current medical regimen and not to make any dose changes or add new drugs, unless indicated by their primary care provider. Impulse oscillometry will be measured at V1 and 4-6 weeks later at V3 to assess effect of the nPEP device on airway physiology. A lung CT scan will be performed at V2.

RETROSPECTIVE:

This device was tried on two individuals and it was initiative and was beneficial. Many patients are not candidates for tracheobronchoplasty itself due to medical comorbidities, prefer to avoid the associated risks, or are not candidates for the required tracheal stenting due to trachea size or anatomy. These patients are left without a viable therapeutic option for their severe cough.