External Pharyngeal Exerciser and Dysphagia

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05708898
Status
Recruiting
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Conditions

  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pharyngeal exerciser — DEVICE
  • sham pharyngeal exerciser — DEVICE

Study Details

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

Key Dates

Start date
Jun 9, 2015
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pharyngeal exerciser group
    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.
  • Sham Comparator: 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.

Primary Outcome Measure

maximum anterior hyoid excursion [ Time Frame: Before six weeks exerciser regimen ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53086-

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Medical College of Wisconsin· Milwaukee, WI

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