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

NCT ID: NCT04114604

Last Updated: 2023-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-30

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injuries Deglutition Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Spinal Cord Injury

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

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catriona Steele

Role: PRINCIPAL_INVESTIGATOR

KITE - Toronto Rehabilitation Institute, University Health Network

Locations

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Toronto Rehabilitation Institute - Lyndhurst Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5R01DC011020

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CAPCR 16-6310

Identifier Type: OTHER

Identifier Source: secondary_id

16-6310

Identifier Type: -

Identifier Source: org_study_id

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