Clinical trial · Interventional
Training Swallowing Initiation During Expiration
Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oropharyngeal Dysphagia | — | UNRESOLVED | — |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Respiratory-Swallow Phase Training | Behavioral | — | UNRESOLVED |
| Swallow Practice | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Respiratory-Swallow Phase Training
- description
- Participants will be trained to initiate swallowing during expiration.
- interventionNames
- Behavioral: Respiratory-Swallow Phase Training
- type
- SHAM_COMPARATOR
- label
- Swallow Practice
- description
- Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).
- interventionNames
- Other: Swallow Practice
Primary outcomes (2)
- measure
- Change in frequency (%) of swallows initiated during expiration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available