Head and Neck CancerNCT05278039
Training Swallowing Initiation During Expiration
A study testing Respiratory-Swallow Phase Training and Swallow Practice in people with Head and Neck Cancer and Dysphagia, run by Northwestern University at 2 sites in United States.
Trial summary
Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Dysphagia, Oropharyngeal Dysphagia
- What is being tested?
- Respiratory-Swallow Phase Training and Swallow Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 May 2022to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of primary head and neck cancer
- Three or more months post-completion of first-line cancer treatment
- English speaking
- Functional/corrected visual and hearing acuity
- No current alcohol or other drug abuse
- Without very severe (forced expiratory volume; FEV) 1 <30% predicted) stage Chronic Obstructive Pulmonary Disease (COPD) based on Pulmonary Function Testing (PFT)
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- No skin allergy to the medical-grade sensor adhesive
- Tolerate wearing the sensor for at least 10 hours/day
- Tolerate some liquid oral intake on a routine basis
- Normal dexterity to self-administer liquids via teaspoon
- Initiation of swallowing during inspiratory phase of respiration on ≥20% of swallows
- Penetration Aspiration Scale (PAS) score ≥3 or impairment on at least one MBSImP OI score (laryngeal vestibular closure ≥1, tongue base retraction ≥2, or pharyngeal residue ≥2) on at least one swallow during lateral view of MBSS
- A PAS score of ≤6 on at least one liquid consistency without the use of a compensatory strategy or swallow maneuver
Who cannot join
- Persistent or recurrent cancer at the time of enrollment
- Known allergy to contrast materials or liquids used during the MBSS or training
- Known allergy to sensor adhesive
- Unable to demonstrate competency with the user-friendly technology
- Diagnosis of neurological disorders
- Indwelling tracheostomy tube
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- Nasogastric (NG) feeding tube
- History of aspiration pneumonia within the past 12 months
- Unable to self-administer liquid boluses
- Unable to swallow some liquids without a maneuver
- Likely or currently pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Northwestern University
Evanston, Illinois, 60208
About this study
Official title: Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer
Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.
Read the detailed description
Head and neck cancers (HNC) have increased to epidemic levels in the United States. Despite good response to cancer treatment, survivors are suffering life-long toxicities that result in swallowing problems (dysphagia). Treatment options for dysphagia after HNC are extremely limited, focus on swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning. Prior evidence has demonstrated that when aberrant respiratory-swallow phase patterning is present (initiation of swallowing during inspiration) in patients with HNC, there is a higher occurrence of swallowing impairments, increased residue, and airway invasion. Further, it has been well established that the expiratory limb of the respiratory cycle provides a biomechanically advantageous set point in which to initiate safe and efficient swallowing. This randomized, controlled, Phase II clinical trial examines if respiratory-swallow phase training improves airway protection and swallowing efficiency in HNC survivors who are three or more months post-completion of first-line cancer treatment. The primary goal (Aim 1) is to determine if respiratory-swallow phase training results in increased frequency (%) of swallows initiated during expiration and improved swallowing safety. The secondary goal (Aim 2) is to examine the impact of respiratory-swallow phase training on the frequency of swallows initiated during expiration in wakeful, naturalistic swallowing environments, including eating and drinking. The investigators will recruit 88 HNC survivors with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. The investigators will deliver therapy remotely using a telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory-swallow movements. Endpoints will be measured from synchronized videofluoroscopic and respiratory-swallow sensor recordings at baseline, within 1-week post-treatment, and 1-month and 3-months post-treatment.
- Conditions
- Head and Neck Cancer, Dysphagia, Oropharyngeal Dysphagia, Oropharynx Squamous Cell Carcinoma
- Being tested
- Respiratory-Swallow Phase Training, Swallow Practice
- Keywords
- Dysphagia, Swallowing Disorders, Swallowing Rehabilitation, Telehealth, Wearable Sensor, Respiratory-Swallow Coordination, Modified Barium Swallow Study
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory-Swallow Phase TrainingBehavioural
Participants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour.
Swallow PracticeOther
Participants will complete 6 "swallow practice" sessions that will last approximately one hour.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory-Swallow Phase Training | Experimental | Participants will be trained to initiate swallowing during expiration. Receives: Behavioral: Respiratory-Swallow Phase Training |
| Swallow Practice | Sham comparator | Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration). Receives: Other: Swallow Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency (%) of swallows initiated during expiration
Determines percent (frequency) of the target (expiratory phase) for each swallow.
Measured: Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Change in Penetration-Aspiration Scale scores
Measures presence, depth and reaction to penetration and aspiration.
Measured: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 1-8 and higher scores indicate worse outcome.
Secondary outcomes (2)
Change in Normalized Residue Ratio Scale scores
Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS)
Measured: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 0 to 100% and higher scores indicate worse outcome.
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores
Measures physiologic swallowing impairment from observations of MBSS recordings
Measured: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Oral Total scores range from 0-22 and Pharyngeal Total scores range from 0-26 and higher values indicate worse outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start19 May 2022
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Responsible party
- Principal investigator, Bonnie Martin-Harris, Northwestern University
- Investigators
- Bonnie Martin-Harris, PhD, Principal investigator, Northwestern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278039
- Sponsor's protocol ID
- R01CA262502
- Status last verified
- May 2026
- First submitted
- 8 Feb 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05278039
- Acronym / sponsor ID
- R01CA262502
- Conditions
- Head and Neck Cancer, Dysphagia, Oropharyngeal Dysphagia, Oropharynx Squamous Cell Carcinoma
- Keywords
- Dysphagia, Swallowing Disorders, Swallowing Rehabilitation, Telehealth, Wearable Sensor, Respiratory-Swallow Coordination, Modified Barium Swallow Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Study start
- 19 May 2022 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 14 Mar 2022 (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.
Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.
Detailed description
Head and neck cancers (HNC) have increased to epidemic levels in the United States. Despite good response to cancer treatment, survivors are suffering life-long toxicities that result in swallowing problems (dysphagia). Treatment options for dysphagia after HNC are extremely limited, focus on swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning. Prior evidence has demonstrated that when aberrant respiratory-swallow phase patterning is present (initiation of swallowing during inspiration) in patients with HNC, there is a higher occurrence of swallowing impairments, increased residue, and airway invasion. Further, it has been well established that the expiratory limb of the respiratory cycle provides a biomechanically advantageous set point in which to initiate safe and efficient swallowing. This randomized, controlled, Phase II clinical trial examines if respiratory-swallow phase training improves airway protection and swallowing efficiency in HNC survivors who are three or more months post-completion of first-line cancer treatment. The primary goal (Aim 1) is to determine if respiratory-swallow phase training results in increased frequency (%) of swallows initiated during expiration and improved swallowing safety. The secondary goal (Aim 2) is to examine the impact of respiratory-swallow phase training on the frequency of swallows initiated during expiration in wakeful, naturalistic swallowing environments, including eating and drinking. The investigators will recruit 88 HNC survivors with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. The investigators will deliver therapy remotely using a telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory-swallow movements. Endpoints will be measured from synchronized videofluoroscopic and respiratory-swallow sensor recordings at baseline, within 1-week post-treatment, and 1-month and 3-months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Respiratory-Swallow Phase Training | Experimental | Behavioral: Respiratory-Swallow Phase TrainingParticipants will be trained to initiate swallowing during expiration. |
| Swallow Practice | Sham comparator | Other: Swallow PracticeParticipants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of primary head and neck cancer
- Three or more months post-completion of first-line cancer treatment
- English speaking
- Functional/corrected visual and hearing acuity
- No current alcohol or other drug abuse
Key exclusion criteria (11 listed)
- Persistent or recurrent cancer at the time of enrollment
- Known allergy to contrast materials or liquids used during the MBSS or training
- Known allergy to sensor adhesive
- Unable to demonstrate competency with the user-friendly technology
- Diagnosis of neurological disorders
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 |
|---|---|---|
| Respiratory-Swallow Phase TrainingParticipants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour. | Behavioural | Respiratory-Swallow Phase Training |
| Swallow PracticeParticipants will complete 6 "swallow practice" sessions that will last approximately one hour. | Other | Swallow Practice |
Primary outcome
Change in frequency (%) of swallows initiated during expiration
Time frame: Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Determines percent (frequency) of the target (expiratory phase) for each swallow.
Change in Penetration-Aspiration Scale scores
Time frame: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 1-8 and higher scores indicate worse outcome.
Measures presence, depth and reaction to penetration and aspiration.
2 secondary outcomes
Change in Normalized Residue Ratio Scale scores
Time frame: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 0 to 100% and higher scores indicate worse outcome.
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores
Time frame: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Oral Total scores range from 0-22 and Pharyngeal Total scores range from 0-26 and higher values indicate worse outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Bonnie Martin-Harris, PhD principal investigator
Northwestern Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory-Swallow Phase Training and Swallow Practice in people with Head and Neck Cancer and Dysphagia, run by Northwestern University at 2 sites 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 13 inclusion and 11 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: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency (%) of swallows initiated during expiration (time frame: Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.). The study lists 2 primary outcomes in all. 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 14 May 2026.