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Behavioural Intervention

Swallow Muscle Exercises for Swallowing Disorders

N/A

Recruiting

Led By Reza Shaker

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after six weeks exerciser regimen, during deglutitive restriction of the larynx

Awards & highlights

Study Summary

This trial will study how swallowing affects the muscles in the throat for better understanding of how it works.

Who is the study for?

This trial is for adults aged 18 to 90 with difficulty swallowing (dysphagia) but normal esophageal muscle function tests. It's not for those under 18, recent head and neck cancer patients, people allergic to lidocaine or barium, pregnant or lactating women, medically unstable individuals, those unable to use a swallow muscle exerciser even with help, cognitively impaired persons, or patients with certain muscle and neuromuscular diseases.Check my eligibility

What is being tested?

The study is testing how the muscles in the throat affect swallowing by using special imaging techniques before and after six weeks of exercises designed to strengthen these muscles. Participants will undergo assessments with and without restricting throat movements.See study design

What are the potential side effects?

Potential side effects may include discomfort from the laryngeal restriction procedure or from using the swallow muscle exercising device. Allergic reactions could occur in participants sensitive to materials used during assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after six weeks exerciser regimen, during deglutitive restriction of the larynx

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after six weeks exerciser regimen, during deglutitive restriction of the larynx

This trial's timeline: 3 weeks for screening, Varies for treatment, and after six weeks exerciser regimen, during deglutitive restriction of the larynx for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

UES anterior-posterior maximum diameter during swallows

hypopharyngeal intra-bolus

maximum excursion of the hyo-laryngeal complex

+3 more

Trial Design

3Treatment groups

Active Control

Group I: Striated esophagus deglutitive motor function healthy adultsActive Control2 Interventions

Testing of manometric, impedance and biomechanical measurements during swallowing in healthy volunteer adult subjects.

Group II: Striated esophagus deglutitive motor function in patients with ineffective esophageal motilityActive Control2 Interventions

Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with ineffective esophageal motility.

Group III: Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometryActive Control2 Interventions

Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with symptoms of dysphagia but "normal" esophageal manometry by the Chicago Classification criteria.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,026 Total Patients Enrolled

Reza ShakerPrincipal InvestigatorMedical College of Wisconsin

1 Previous Clinical Trials

350 Total Patients Enrolled

Media Library

Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05708885 — N/A

Esophageal Dysphagia Research Study Groups: Striated esophagus deglutitive motor function healthy adults, Striated esophagus deglutitive motor function in patients with ineffective esophageal motility, Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometry

Esophageal Dysphagia Clinical Trial 2023: Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device Highlights & Side Effects. Trial Name: NCT05708885 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project admit individuals younger than 45 years of age?

"This clinical trial is searching for participants aged 18 and above, but below 90 years old."

Answered by AI

What is the limit to the number of individuals participating in this clinical trial?

"Affirmative. Information on clinicaltrials.gov suggests that the specified research is actively searching for volunteers, with an initial post date of September 13th 2022 and a last update occurring February 8th 2023. This trial requires 557 patients to be enlisted at 1 centre."

Answered by AI

Are researchers currently seeking participants for this experiment?

"Affirmative. According to clinicaltrials.gov, this trial is currently open for enrollment and was first posted on September 13th 2022 before being revised last February 8th 2023. A total of 557 participants are required across a single medical site."

Answered by AI

To whom is this trial open for enrollment?

"Patients who wish to be considered for this trial must meet the criteria of esophageal dysphagia and fall within the age range of 18-90. This clinical study is enrolling a total of 557 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Striated Esophageal Motor Function Modulation in Health and Disease

Reza Shaker, MD 2022. "Striated Esophageal Motor Function Modulation in Health and Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05708885.