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Completed

NCT Number: NCT05235282

Effect of Oral Neuromuscular Training on Swallowing

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Central Jutland, 8450, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cuff tracheostomy tube

Exclusion criteria

  • Not able to comply with IQoro exercises
  • 3 weeks evaluation stay at the hospital

Treatment and study plan

IQoro

Device

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 function

Other

Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control

Primary outcomes

  1. 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.

Secondary outcomes

  1. Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)

    Time frame: Baseline and after four weeks

    FEDSS is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. FEDSS range is 1-6, with lower scores representing better outcome

  2. Penetration Aspiration Scale (PAS)

    Time frame: Baseline and after four weeks

    PAS is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. PAS range is 1-8, with lower scores representing better outcome

  3. Yale Pharyngeal Residue Scale

    Time frame: Baseline and after four weeks

    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.

  4. Milliliters of saliva above the cuff

    Time frame: Daily measures for up to four weeks

    Daily amount of saliva above the cuff of the tracheostomy tube

  5. Functional oral intake (FOIS)

    Time frame: Baseline and after four weeks

    FOIS range is 1-7, with 7 representing better outcome

  6. Iowa Oral Performance Instrument (IOPI)

    Time frame: Baseline and after four weeks

    Lip strength measured with the IOPI. Measured in Pascal with greater values representing greater strength

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Hammel Neurorehabilitation Centre and University Research Clinic

Registry information

Official study title

Effect of Oral Neuromuscular Training on Swallowing Function and Time Until Decannulation

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2022
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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