N/A
Completed N=10
Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
Spinal Cord Injuries · Deglutition Disorders
Source: ClinicalTrials.gov NCT04114604 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Number of Participants Displaying Unsafe Swallowing — 0; 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Displaying Unsafe Swallowing |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Displaying Post-swallow Inhalation |
2; 5; 3; 1; 2 | — |
| PRIMARY Duration of the Respiratory Pause Seen in Swallowing |
901; 996; 867; 721; 815 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04114604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.