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

NCT07756684 | Not Yet Recruiting FDA Device

• 1 other identifier: TBD 8-5-26
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Head and Neck Cancers

Keywords

cough skill training

Outcome Measures

Primary Outcomes (1)

• Feasibility of cough skill training

  Feasibility of cough skill training will be defined as the percentage of trials completing during treatment sessions.

  6 weeks

Secondary Outcomes (3)

• Change in voluntary cough peak expiratory flow rate

  baseline, 6 weeks

• Acceptability assessed by the System Usability Scale

  6 weeks

• Satisfaction assessed by the Beck Satisfaction Scale

  6 weeks

Study Arms (1)

Cough skill training

EXPERIMENTAL

Participants will use a handheld cough device to produce voluntary coughs during 5 one hour treatment sessions.

Device: Handheld cough device

Interventions

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.

Cough skill training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Airway Protection Research Lab at Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• James Borders, PhD CCC-SLP

  Boston University Charles River Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Borders, PhD CCC-SLP

CONTACT

617-353-3379; bordersj@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)