N/A N=40

Physiological Flow of Liquids Used in Dysphagia Management (Neuro)

Amyotrophic Lateral Sclerosis · Parkinson Disease · Dysphagia

Bottom Line

View on ClinicalTrials.gov: NCT03192358 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcome: Primary: Number of Participants With Residue of Concern (Observational) — 6; 6; 3; 6 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Videofluoroscopic Swallowing Examination (Diagnostic_test); Tongue Strength Measurement (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Health Network, Toronto
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Residue of Concern (Observational)	6; 6; 3; 6; 4; 2	—
PRIMARY Maximum Anterior Isometric Tongue Pressure	34; 55	< 0.001 sig
PRIMARY Regular Effort Saliva Swallow Tongue Pressure	19; 17	< 0.001 sig
PRIMARY Number of Participants With Unsafe Swallows (Observational)	10; 9; 7; 6; 3; 2	—
SECONDARY Maximum Posterior Isometric Tongue Pressure (Observational).	29; 51	—
SECONDARY Number of Participants With Multiple Swallows Per Bolus (Observational)	6; 8; 9; 5; 8; 6	—
SECONDARY Number of Participants Displaying Prolonged Pharyngeal Bolus Transit (Observational)	5; 10; 7; 7; 8; 5	—

Summary

For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom. Dysphagia places the affected individual at risk for secondary health consequences, including malnutrition and aspiration pneumonia, and negatively affects quality of life. Thickened liquids are commonly recommended for individuals with dysphagia, as they flow more slowly and reduce the risk of entry into the airway. However, there is limited understanding about how changes in liquid thickness modulate swallowing physiology in individuals with neurodegenerative conditions, and previous reports have shown that increased liquid thickness may contribute to the accumulation of residue in the throat. The purpose of this study is to explore swallowing physiology and function in individuals with neurodegenerative conditions, across five levels of liquid thickness (thin, slightly-thick, mildly-thick, moderately-thick, and extremely-thick), and to identify boundaries of "optimal liquid thickness", which maintain airway safety, without contributing to the accumulation of significant residue. Results from this study will help guide the clinical recommendations for thickened liquids in dysphagia management.

Eligibility Criteria

Inclusion Criteria

Adults (18+) with a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) or Parkinson's disease (PD)

Exclusion Criteria

People with a prior medical history of stroke
People with a prior medical history of acquired brain injury
People with a prior medical history of spinal or spinal cord injury
People with a prior medical history of cancer or surgery in the head and neck region
People who have had radiation to the head and neck for cancer
People who have a prior history of swallowing problems (e.g., from childhood, medical complication)
People with significant breathing difficulties (e.g., rely on mechanical ventilation)
People who rely solely on tube-feeding for all meals and nutrition
People who have Type I (insulin-dependent) Diabetes
Women who are pregnant
People who have allergies to barium, potato starch, corn starch, xanthan gum, milk products, latex or dental glue

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03192358). 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.