External Pharyngeal Exerciser and Dysphagia

NCT05708898 | Recruiting FDA Device

• 1 other identifier: PRO00023967
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in patients with dysphagia. The main question it aims to answer is:

• Does application of pharyngeal exerciser improve swallowing as evidenced by need for prescribed intervention for dysphagia (maneuvers, exercises or dietary modification to prevent aspiration). Participants will:
• Perform barium swallows in lateral view fluoroscopy
• Over a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynx
• Return for another fluoroscopic barium swallow study

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (12)

• maximum anterior hyoid excursion

  deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images

  Before six weeks exerciser regimen

• maximum anterior hyoid excursion

  deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images

  after six weeks exerciser regimen

• maximum superior hyoid excursion

  deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images

  Before six weeks exerciser regimen

• maximum superior hyoid excursion

  deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images

  after six weeks exerciser regimen

• maximum anterior laryngeal excursion

  deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images

  Before six weeks exerciser regimen

• maximum anterior laryngeal excursion

  deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images

  after six weeks exerciser regimen

• maximum superior laryngeal excursion

  deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images

  before six weeks exerciser regimen

• maximum superior laryngeal excursion

  deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images

  after six weeks exerciser regimen

• maximum upper esophageal sphincter (UES) anterior-posterior opening

  deglutitive maximum UES diameter measured from fluoroscopic images

  Before six weeks exerciser regimen

• maximum upper esophageal sphincter (UES) anterior-posterior opening

  deglutitive maximum UES diameter measured from fluoroscopic images

  after six weeks exerciser regimen

• pyriform sinus residue

  area (height x width) of pyriform sinus residue measure from fluoroscopic images

  Before six weeks exerciser regimen

• pyriform sinus residue

  area (height x width) of pyriform sinus residue measure from fluoroscopic images

  after six weeks exerciser regimen

Secondary Outcomes (2)

• Penetration and aspiration analyses

  Before six weeks exerciser regimen

• Penetration and aspiration analyses

  after six weeks exerciser regimen

Study Arms (2)

Pharyngeal exerciser group

EXPERIMENTAL

In this group, the device will be placed around the neck overlying the laryngeal cartilage. Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.

Device: Pharyngeal exerciser

Sham exerciser group

SHAM COMPARATOR

In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.

Device: sham pharyngeal exerciser

Interventions

Pharyngeal exerciser DEVICE

Pharyngeal exerciser group

sham pharyngeal exerciser DEVICE

Sham exerciser group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration
• Healthy elderly adult (≥65 years of age).

You may not qualify if:

• Patients younger than 18 years of age.
• Patients with recent head and neck cancer (\<1 month post-surgery or \<3 months post-chemo radiation.
• Patients suffering from muscle diseases like muscular dystrophies, myopathies.
• Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders
• Patients having history of allergy to lidocaine or barium.
• Patients who are pregnant or lactating.
• Patients who are medically unstable.
• Patients who are unable to apply the exerciser independently or with the help of a caregiver.
• Patients who lack cognition.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53086, United States

RECRUITING

Related Publications (16)

• Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clave P. Prevalence and prognostic implications of dysphagia in elderly patients with pneumonia. Age Ageing. 2010 Jan;39(1):39-45. doi: 10.1093/ageing/afp100. Epub 2009 Jun 26.

  PMID: 19561160 BACKGROUND

• Turley R, Cohen S. Impact of voice and swallowing problems in the elderly. Otolaryngol Head Neck Surg. 2009 Jan;140(1):33-6. doi: 10.1016/j.otohns.2008.10.010.

  PMID: 19130958 BACKGROUND

• Bonilha HS, Simpson AN, Ellis C, Mauldin P, Martin-Harris B, Simpson K. The one-year attributable cost of post-stroke dysphagia. Dysphagia. 2014 Oct;29(5):545-52. doi: 10.1007/s00455-014-9543-8. Epub 2014 Jun 20.

  PMID: 24948438 BACKGROUND

• Altman KW, Yu GP, Schaefer SD. Consequence of dysphagia in the hospitalized patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg. 2010 Aug;136(8):784-9. doi: 10.1001/archoto.2010.129.

  PMID: 20713754 BACKGROUND

• Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.

  PMID: 9136821 BACKGROUND

• Altman KW, Schaefer SD, Yu GP, Hertegard S, Lundy DS, Blumin JH, Maronian NC, Heman-Ackah YD, Abitbol J, Casiano RR; Neurolaryngology Subcommittee of the American Academy of Otolaryngology-Head and Neck Surgery. The voice and laryngeal dysfunction in stroke: a report from the Neurolaryngology Subcommittee of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg. 2007 Jun;136(6):873-81. doi: 10.1016/j.otohns.2007.02.032.

  PMID: 17547973 BACKGROUND

• Hamdy S, Aziz Q, Rothwell JC, Crone R, Hughes D, Tallis RC, Thompson DG. Explaining oropharyngeal dysphagia after unilateral hemispheric stroke. Lancet. 1997 Sep 6;350(9079):686-92. doi: 10.1016/S0140-6736(97)02068-0.

  PMID: 9291902 BACKGROUND

• Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.

  PMID: 16269630 BACKGROUND

• Smithard DG, O'Neill PA, Parks C, Morris J. Complications and outcome after acute stroke. Does dysphagia matter? Stroke. 1996 Jul;27(7):1200-4. doi: 10.1161/01.str.27.7.1200.

  PMID: 8685928 BACKGROUND

• Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.

  PMID: 11984518 BACKGROUND

• Shaker R, Kern M, Bardan E, Taylor A, Stewart ET, Hoffmann RG, Arndorfer RC, Hofmann C, Bonnevier J. Augmentation of deglutitive upper esophageal sphincter opening in the elderly by exercise. Am J Physiol. 1997 Jun;272(6 Pt 1):G1518-22. doi: 10.1152/ajpgi.1997.272.6.G1518.

  PMID: 9227489 BACKGROUND

• Logemann JA. Treatment of oral and pharyngeal dysphagia. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):803-16, ix. doi: 10.1016/j.pmr.2008.06.003.

  PMID: 18940642 BACKGROUND

• Shaker R, Geenen JE. Management of Dysphagia in stroke patients. Gastroenterol Hepatol (N Y). 2011 May;7(5):308-32. No abstract available.

  PMID: 21857832 BACKGROUND

• Easterling C, Grande B, Kern M, Sears K, Shaker R. Attaining and maintaining isometric and isokinetic goals of the Shaker exercise. Dysphagia. 2005 Spring;20(2):133-8. doi: 10.1007/s00455-005-0004-2.

  PMID: 16172822 BACKGROUND

• Logemann JA, Rademaker A, Pauloski BR, Kelly A, Stangl-McBreen C, Antinoja J, Grande B, Farquharson J, Kern M, Easterling C, Shaker R. A randomized study comparing the Shaker exercise with traditional therapy: a preliminary study. Dysphagia. 2009 Dec;24(4):403-11. doi: 10.1007/s00455-009-9217-0. Epub 2009 May 27.

  PMID: 19472007 BACKGROUND

• Kahrilas PJ, Logemann JA, Krugler C, Flanagan E. Volitional augmentation of upper esophageal sphincter opening during swallowing. Am J Physiol. 1991 Mar;260(3 Pt 1):G450-6. doi: 10.1152/ajpgi.1991.260.3.G450.

  PMID: 2003609 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Reza Shaker, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Shaker, MD

CONTACT

4149556840; rshaker@mcw.edu

Mark Kern

CONTACT

414-805-3826; mkern@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Provost for Clinical and Translational Research, Senior Associate Dean and Director of the Clinical and Translational Science Institute of SE WI, and the Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology

Model Details: Pharyngeal exerciser group: In this group, the device will be placed around the neck overlying the laryngeal cartilage using the Velcro fastening in the back of neck. The externally applied pressure will be measured via the pressure gauge included in the device (see figure). Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks. Sham exerciser group: In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 1, 2023
• Study Start: June 9, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)