# Training Swallowing Initiation during Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer

> **NIH NIH R01** · NORTHWESTERN UNIVERSITY · 2022 · $580,489

## Abstract

PROJECT SUMMARY ABSTRACT
Oropharyngeal head and neck cancers (OP HNC) have increased to epidemic levels in the United States.1,2
Despite good response to cancer treatment,3 survivors are suffering life-long toxicities that result in swallowing
problems (dysphagia).4,5 Treatment options for dysphagia after OP HNC are extremely limited, focus on
swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning.6-11
Prior evidence has demonstrated that
of
impairments,
when aberrant respiratory-swallow phase patterning is present ( initiation
 swallowing during nspiration ) in patients with OP HNC, there is a higher occurrence of swallowing
increased residue, and airway invasion. 12,13
i
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.14-17 Thus, we developed and tested an innovative approach to train individuals with
dysphagia after OP HNC to initiate swallowing during expiration.18 In this preliminary trial, we found that training
initiation of swallowing during expiration resulted in marked improvements in airway protection and key
physiologic components of swallowing function.18 These compelling findings led us to the current randomized,
Phase II, sham-controlled clinical trial to test if this respiratory-swallow phase training approach will improve
airway protection and swallowing efficiency in OP HNC survivors in the subacute phase (3-6 mo.) of recovery.
Our 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. Our 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. We will recruit 88 OP HNC survivors
with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. They will be
randomized 1:1 into Experimental (n=44) or Sham (n=44) group arms. We will deliver therapy remotely using a
telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory-
swallow movements. Primary endpoints for Aim 1: frequency (%) of swallows initiated during expiration and
Penetration-Aspiration Scale19 scores. Secondary endpoints: Normalized Residue Ratio Scale20 and Modified
Barium Swallow Impairment Profile21,22 scores. 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. The primary endpoint for Aim 2 is frequency (%) of swallows initiated during expiration in wakeful,
natural contexts measured at baseline, during training, within 1-week post-treatment, and 2-, 4-, 6-, 8-, 10-, and
12-weeks post...

## Key facts

- **NIH application ID:** 10469004
- **Project number:** 5R01CA262502-02
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** BONNIE J MARTIN-HARRIS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $580,489
- **Award type:** 5
- **Project period:** 2021-08-12 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10469004

## Citation

> US National Institutes of Health, RePORTER application 10469004, Training Swallowing Initiation during Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer (5R01CA262502-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10469004. Licensed CC0.

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