DysphagiaNCT05235282
Effect of Oral Neuromuscular Training on Swallowing
A study testing IQoro in people with Dysphagia, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- IQoro
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2022to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cuff tracheostomy tube
Who cannot join
- Not able to comply with IQoro exercises
- 3 weeks evaluation stay at the hospital
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Central Jutland, 8450
About this study
Official title: Effect of Oral Neuromuscular Training on Swallowing Function and Time Until Decannulation
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.
- Conditions
- Dysphagia
- Being tested
- IQoro, Usual care for swallowing function
- Keywords
- Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQoroDevice
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.
Usual care for swallowing functionOther
Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control
| Study group | Role | What they receive |
|---|---|---|
| Usual care + IQoro | Experimental | The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen Receives: Device: IQoro; Other: Usual care for swallowing function |
| Usual care | Active comparator | The comparison group receives usual training of swallowing function Receives: Other: Usual care for swallowing function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Number of days from baseline assessment until decannulation or right censoring at 365 days
Secondary outcomes (6)
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
Measured: Baseline and after four weeks
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
Measured: Baseline and after four weeks
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.
Measured: Baseline and after four weeks
Milliliters of saliva above the cuff
Daily amount of saliva above the cuff of the tracheostomy tube
Measured: Daily measures for up to four weeks
Functional oral intake (FOIS)
FOIS range is 1-7, with 7 representing better outcome
Measured: Baseline and after four weeks
Iowa Oral Performance Instrument (IOPI)
Lip strength measured with the IOPI. Measured in Pascal with greater values representing greater strength
Measured: Baseline and after four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start6 May 2022
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Hammel Neurorehabilitation Centre and University Research Clinic
- Responsible party
- Sponsor
- Investigators
- Jesper Fabricius, PhD, Principal investigator, Hammel Neurorehabilitation Centre and University Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235282
- Sponsor's protocol ID
- 764706
- Status last verified
- Apr 2024
- First submitted
- 18 Jan 2022
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Neuromuscular Training on Swallowing Function and Time Until Decannulation
- ClinicalTrials.gov ID
- NCT05235282
- Acronym / sponsor ID
- 764706
- Conditions
- Dysphagia
- Keywords
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Hammel Neurorehabilitation Centre and University Research Clinic
- Study start
- 6 May 2022 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care + IQoro | Experimental | Device: IQoro, Other: Usual care for swallowing functionThe intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen |
| Usual care | Active comparator | Other: Usual care for swallowing functionThe comparison group receives usual training of swallowing function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cuff tracheostomy tube
Key exclusion criteria (2 listed)
- Not able to comply with IQoro exercises
- 3 weeks evaluation stay at the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQoroAn 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. | Device | Usual care + IQoro |
| Usual care for swallowing functionCuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control | Other | Usual care, Usual care + IQoro |
Primary outcome
Number of days from admission until decannulation
Time frame: Number of days from baseline assessment until decannulation or right censoring at 365 days
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.
6 secondary outcomes
Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
Time frame: Baseline and after four weeks
Penetration Aspiration Scale (PAS)
Time frame: Baseline and after four weeks
Yale Pharyngeal Residue Scale
Time frame: Baseline and after four weeks
Milliliters of saliva above the cuff
Time frame: Daily measures for up to four weeks
Functional oral intake (FOIS)
Time frame: Baseline and after four weeks
Iowa Oral Performance Instrument (IOPI)
Time frame: Baseline and after four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Fabricius, PhD principal investigator
Hammel Neurorehabilitation Centre and University Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQoro in people with Dysphagia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days from admission until decannulation (time frame: Number of days from baseline assessment until decannulation or right censoring at 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.