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Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Spinal Cord Injuries
Deglutition Disorders

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04114604
16-6310
CAPCR 16-6310 (Other Identifier)
5R01DC011020 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing.The focus of this study is to evaluate the flow of liquids of varying consistency in the spinal disorder population.

Full description

Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). However, the field lacks a clear understanding of how liquids of different consistencies behave during swallowing. In order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx. This study explores this question in individuals with spinal cord injury. Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, mildly thick, moderately thick and extremely thick). Swallowing will be observed under videofluoroscopy. Simultaneous measures of airflow via nasal cannula will be used to study respiratory-swallow coordination in this study sample.

Enrollment

10 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Spinal cord injury at the cervical or thoracic level (T6 or higher)

Exclusion criteria

  • Prior history of swallowing, motor speech, gastro-esophageal difficulties, chronic sinusitis or taste disturbance.
  • Neurological difficulties unrelated to spinal disorder (e.g. Stroke, Parkinson disease, etc).
  • Cognitive communication difficulties that may hinder ability to participate.
  • Current use of mechanical ventilation
  • External instrumentation around the head/neck that would obstruct the field of view during the videofluoroscopy exam (e.g. cervical collar).
  • Type 1 Diabetes (due to the requirement to swallow stimuli containing starch based thickeners, which carry a significant carbohydrate load).
  • Known allergies to latex, food coloring or dental glue (due to the probability that these items will come into contact with the oral mucosa during data collection).
  • Children and pregnant women (due to the use of radiation during the videofluoroscopic examination).

Trial design

10 participants in 1 patient group

Spinal Cord Injury
Description:
Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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