NCT07606547

Brief Summary

The aim of this non-randomized intervention study is to investigate the detailed effects of a structured four-week EMST® training program on the biomechanics of swallowing function in dysphagic Parkinson's patients. A combination of fiberoptic endoscopic evaluation of swallowing (FEES) and pharyngeal high-resolution manometry (HRM) will be employed to comprehensively evaluate the neuromuscular changes in swallowing.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026May 2028

First Submitted

Initial submission to the registry

May 6, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

May 6, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

DysphagiaExpiratory muscle strength trainingParkinson's DiseaseHigh-resolution pharyngeal manometry

Outcome Measures

Primary Outcomes (1)

  • Effect on swallowing biomechanics in pharyngeal high-resolution manometry as assessed by measurement of e.g. Pharyngeal contractile Integral (PhcI)

    metrics of pharyngeal contraction and upper esophageal sphinkter opening in high-resolution pharyngeal manometry

    1 month and 3 months

Secondary Outcomes (1)

  • Pharyngeal swallowing safety and efficiency as assessed with fiberoptic endoscopic evaluation of swallowing (FEES) applying DIGEST-FEES scoring

    1 month and 3 months

Study Arms (1)

EMST treatment

EXPERIMENTAL

daily EMST training on 5 days a week for 1 month

Device: exspiratory muscle strength training

Interventions

5 sets of 5 breaths with EMST per day, 5 days a week for 1 month

Also known as: EMST
EMST treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Parkinson's disease,
  • PD-related dysphagia as objectively diagnosed with FEES

You may not qualify if:

  • severe dementia, not able to give consent
  • dysphagia related to other diagnoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Münster, Department of Neurology

Münster, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseDeglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Sonja Suntrup-Krueger, Prof. Dr. med.

    University Hospital Münster, Department of Neurology, Albert-Schweitzer-Campus 1, A1, 48149 Münster, Germany

    STUDY CHAIR

Central Study Contacts

Sonja Suntrup-Krueger, Prof. Dr. med.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 26, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations