Head and Neck CancersNCT07756684
Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer
A study testing Handheld cough device in people with Head and Neck Cancers, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers
- What is being tested?
- Handheld cough device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior diagnosis of head and neck cancer at least 6 months post-diagnosis
- Completed treatment for head and neck cancer, including surgery, radiation, or chemotherapy
- Medically stable and able to follow commands and produce a voluntary cough
- English speaking
Who cannot join
- Unable to provide informed consent assessed by a Montreal Cognitive Assessment (MoCA) score of <20
- Unable to follow study instructions
- Unable to produce a voluntary cough
- History of neurologic disease
- Recent laryngeal surgery or vocal fold injury
- Active respiratory infection or febrile illness within the past 14 days
Show all 12Show fewer
- Chronic, severe, or unstable respiratory disease
- Asthma or bronchitis
- Smoking within the past five years
- Uncontrolled hypertension
- Recent myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within the past 6 months
- Significant uncontrolled arrhythmia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Airway Protection Research Lab at Boston University
Boston, Massachusetts, 02215
James Borders, PhD CCC-SLP, 617-353-3379, Aprlab@bu.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancers
- Being tested
- Handheld cough device
- Keywords
- cough skill training
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld cough deviceDevice
During each treatment session with study personnel and during home practice, participants will complete 25 repetitions (5 sets of 5) of a voluntary coughs.
| Study group | Role | What they receive |
|---|---|---|
| Cough skill training | Experimental | Participants will use a handheld cough device to produce voluntary coughs during 5 one hour treatment sessions. Receives: Device: Handheld cough device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of cough skill training
Feasibility of cough skill training will be defined as the percentage of trials completing during treatment sessions.
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start28 Oct 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Borders, PhD CCC-SLP, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756684
- Sponsor's protocol ID
- 8575
- Status last verified
- Nov 2026
- First submitted
- 7 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07756684
- Acronym / sponsor ID
- 8575
- Conditions
- Head and Neck Cancers
- Keywords
- cough skill training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 28 Oct 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cough skill training | Experimental | Device: Handheld cough deviceParticipants will use a handheld cough device to produce voluntary coughs during 5 one hour treatment sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prior diagnosis of head and neck cancer at least 6 months post-diagnosis
- Completed treatment for head and neck cancer, including surgery, radiation, or chemotherapy
- Medically stable and able to follow commands and produce a voluntary cough
- English speaking
Key exclusion criteria (12 listed)
- Unable to provide informed consent assessed by a Montreal Cognitive Assessment (MoCA) score of <20
- Unable to follow study instructions
- Unable to produce a voluntary cough
- History of neurologic disease
- Recent laryngeal surgery or vocal fold injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handheld cough deviceDuring each treatment session with study personnel and during home practice, participants will complete 25 repetitions (5 sets of 5) of a voluntary coughs. | Device | Cough skill training |
Primary outcome
Feasibility of cough skill training
Time frame: 6 weeks
Feasibility of cough skill training will be defined as the percentage of trials completing during treatment sessions.
3 secondary outcomes
Change in voluntary cough peak expiratory flow rate
Time frame: baseline, 6 weeks
Acceptability assessed by the System Usability Scale
Time frame: 6 weeks
Satisfaction assessed by the Beck Satisfaction Scale
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Borders, PhD CCC-SLP principal investigator
Boston University Charles River Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld cough device in people with Head and Neck Cancers, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Borders, PhD CCC-SLP (617-353-3379, Aprlab@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of cough skill training (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.