Effect of Oral Neuromuscular Training on Swallowing
Primary Purpose
Dysphagia
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
IQoro
Usual care for swallowing function
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia
Eligibility Criteria
Inclusion Criteria:
- Cuff tracheostomy tube
Exclusion Criteria:
- Not able to comply with IQoro exercises
- 3 weeks evaluation stay at the hospital
Sites / Locations
- Hammel Neurorehabilitation Centre and University Research ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Usual care + IQoro
Usual care
Arm Description
The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen
The comparison group receives usual training of swallowing function
Outcomes
Primary Outcome Measures
Number of days from admission until decannulation
Time from admission until decannulation from a tracheostomy tube. For patients still admitted, decannulation is determined from the clinicians and documented i medical records. For discharged patients, decannulation is determined through medical records.
Secondary Outcome Measures
Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
FEDSS is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. FEDSS range is 1-6, with lower scores representing better outcome
Penetration Aspiration Scale (PAS)
PAS is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. PAS range is 1-8, with lower scores representing better outcome
Yale Pharyngeal Residue Scale
Yale Pharyngeal Residue Scale is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. The Yale Scale encompass two subscales with score 1-5 on each scale, with 1 representing better outcome.
Milliliters of saliva above the cuff
Daily amount of saliva above the cuff of the tracheostomy tube
Functional oral intake (FOIS)
FOIS range is 1-7, with 7 representing better outcome
Iowa Oral Performance Instrument (IOPI)
Lip strength measured with the IOPI. Measured in Pascal with greater values representing greater strength
Full Information
NCT ID
NCT05235282
First Posted
January 18, 2022
Last Updated
August 14, 2023
Sponsor
University of Aarhus
Collaborators
Hammel Neurorehabilitation Centre and University Research Clinic
1. Study Identification
Unique Protocol Identification Number
NCT05235282
Brief Title
Effect of Oral Neuromuscular Training on Swallowing
Official Title
Effect of Oral Neuromuscular Training on Swallowing Function and Time Until Decannulation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Hammel Neurorehabilitation Centre and University Research Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this randomized controlled trial the investigators wish to investigate the effect of an oral neuromuscular training device (called IQoro) on swallowing function and time until decannulation from a tracheostomy tube, in patients admitted for neurorehabilitation due to a severe acquired brain injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Dysphagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care + IQoro
Arm Type
Experimental
Arm Description
The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
The comparison group receives usual training of swallowing function
Intervention Type
Device
Intervention Name(s)
IQoro
Intervention Description
An acrylic mouth guard with a pulling loop. The mouth guard is placed in the mouth of the patient on the outside of the teeth. The therapist pulls the loop in different directions and the patient try to close his/her mouth on the mouth guard to keep it inside the mouth.
Intervention Type
Other
Intervention Name(s)
Usual care for swallowing function
Intervention Description
Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control
Primary Outcome Measure Information:
Title
Number of days from admission until decannulation
Description
Time from admission until decannulation from a tracheostomy tube. For patients still admitted, decannulation is determined from the clinicians and documented i medical records. For discharged patients, decannulation is determined through medical records.
Time Frame
Number of days from baseline assessment until decannulation or right censoring at 365 days
Secondary Outcome Measure Information:
Title
Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
Description
FEDSS is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. FEDSS range is 1-6, with lower scores representing better outcome
Time Frame
Baseline and after four weeks
Title
Penetration Aspiration Scale (PAS)
Description
PAS is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. PAS range is 1-8, with lower scores representing better outcome
Time Frame
Baseline and after four weeks
Title
Yale Pharyngeal Residue Scale
Description
Yale Pharyngeal Residue Scale is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. The Yale Scale encompass two subscales with score 1-5 on each scale, with 1 representing better outcome.
Time Frame
Baseline and after four weeks
Title
Milliliters of saliva above the cuff
Description
Daily amount of saliva above the cuff of the tracheostomy tube
Time Frame
Daily measures for up to four weeks
Title
Functional oral intake (FOIS)
Description
FOIS range is 1-7, with 7 representing better outcome
Time Frame
Baseline and after four weeks
Title
Iowa Oral Performance Instrument (IOPI)
Description
Lip strength measured with the IOPI. Measured in Pascal with greater values representing greater strength
Time Frame
Baseline and after four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cuff tracheostomy tube
Exclusion Criteria:
Not able to comply with IQoro exercises
3 weeks evaluation stay at the hospital
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Fabricius, PhD
Phone
78419051
Email
Jesper.Fabricius@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Fabricius, PhD
Organizational Affiliation
Hammel Neurorehabilitation Centre and University Research Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammel Neurorehabilitation Centre and University Research Clinic
City
Hammel
State/Province
Midtjylland
ZIP/Postal Code
8450
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper Fabricius, PhD
Phone
78419051
Email
Jesper.Fabricius@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Oral Neuromuscular Training on Swallowing
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