An interventional study of Handheld cough device in Head and Neck Cancers, sponsored by Boston University Charles River Campus. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Device feasibility
This preliminary study will examine the feasibility of a cough skill training treatment approach to rehabilitate voluntary cough function in people with head and neck cancer. Cough skill training focuses on practicing cough as a compensatory strategy for when food or liquid enters the airway. Primary outcomes will be feasibility and immediate treatment effects. The investigators hypothesize that the treatment will be feasible and will result in improvements to voluntary cough peak expiratory flow rate.
Participants will complete an initial in-person baseline evaluation of voluntary cough function, followed by five weekly telehealth treatment sessions for five weeks with home practice, before completing a post-treatment in-person evaluation. During each treatment session with study personnel and during home practice, they will complete 25 repetitions (5 sets of 5) of voluntary coughs.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 10 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Boston University Charles River Campus is the lead sponsor of 159 studies on the registry; 33 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 9 (64%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use a handheld cough device to produce voluntary coughs during 5 one hour treatment sessions.
Device: Handheld cough device
During each treatment session with study personnel and during home practice, participants will complete 25 repetitions (5 sets of 5) of a voluntary coughs.
Feasibility of cough skill training
Feasibility of cough skill training will be defined as the percentage of trials completing during treatment sessions.
Time frame: 6 weeks
Change in voluntary cough peak expiratory flow rate
Peak expiratory flow rate is a measure of cough strength. Changes in cough strength from pretraining to post training will be recorded.
Time frame: baseline, 6 weeks
Acceptability assessed by the System Usability Scale
The System Usability Scale (SUS) is a quick, 10-item questionnaire used to measure how people feel about the ease of use of a product, app, or website. Users reply using a 5-point scale from strongly disagree to strongly agree, resulting in an overall score from 0 to 100, with higher scores associated with greater acceptability.
Time frame: 6 weeks
Satisfaction assessed by the Beck Satisfaction Scale
The 5-item satisfaction and acceptability scale used by Beck et al. (2017) measures treatment experience across five domains on a 5-point scale from 1=very unsatisfied to 5=very satisfied. It evaluates technology/tools, treatment tasks, convenience, organization/clinician interaction, and overall treatment satisfaction. Scores can range from 5 to 25 with higher scores associated with greater satisfaction.
Time frame: 6 weeks
Plan to share: Yes — Deidentified analysis data will be stored in a public repository (Open Science Framework) upon publication. This data will only be used to reproduce the primary results of the study.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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