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NCT Number: NCT07756684

Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer

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.

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Key information

Conditions

Head and Neck Cancers Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Airway Protection Research Lab at Boston University

Boston, Massachusetts, 02215, United States

Location contact

James Borders, PhD CCC-SLP

CONTACT

[email protected]

617-353-3379

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Handheld cough device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in voluntary cough peak expiratory flow rate

    Time frame: baseline, 6 weeks

    Peak expiratory flow rate is a measure of cough strength. Changes in cough strength from pretraining to post training will be recorded.

  2. Acceptability assessed by the System Usability Scale

    Time frame: 6 weeks

    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.

  3. Satisfaction assessed by the Beck Satisfaction Scale

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

James Borders, PhD CCC-SLP

CONTACT

[email protected]

617-353-3379

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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