Colorado Oral Strengthening Device

NCT05464225 | Completed DMC

• 1 other identifier: 19-1850
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

University of Colorado is looking for adults with Parkinson's disease to participate in a research study. The study aims to explore how a novel low technology device can achieve an increase in tongue strength comparable to standard of care exercise using tongue depressors but with the kinematics and simple biofeedback of existing high cost devices. Research has shown that tongue resistance exercises paired with biofeedback have resulted in improved tongue strength to support chewing, control of food and liquid in the mouth, and propulsion of material for a swallow.

Conditions

Parkinson Disease

Keywords

tongue strength; novel exercise

Outcome Measures

Primary Outcomes (1)

• Change in Tongue Strength, as measured in kPa via IOPI

  Tongue Strength, as measured in kPa via IOPI with measurements that are equal to or higher compared to baseline at follow-up visits at weeks 2,3,6 and 8 from initial visit. Tongue strength will be assessed using The Iowa Oral Pressure Instrument (IOPI). IOPI measures tongue strength with max pressure (kPa) ranging from 0 to 110 with an average of 50-60 kPa depending on age. Higher kPa is associated with increased tongue strength.

  Baseline, up to 8 weeks.

Study Arms (2)

COSD

EXPERIMENTAL

Participants assigned to the COSD, will use the investigational device.

Device: COSD

SOC

ACTIVE COMPARATOR

Tongue depressors are the standard-of-care so the control group will use these instead of the investigational "Colorado Oral Strengthening Device."

Device: SOC

Interventions

COSD DEVICE

The exercise protocol will include using the tongue to compress the COSD against the hard palate, or against the tongue depressor for 30 repetitions, 3 times per day, on 3 days of the 7-day week. For the first week, the participants who are in the COSD group will be issued a COSD bulb that corresponds to no less than 60% of their baseline maximum strength. After week 1, they will switch to a COSD bulb that corresponds to no less than 80% of their maximum tongue strength for the remaining 7 weeks.

COSD

SOC DEVICE

The exercise protocol will include using the tongue to compress the COSD against the hard palate, or against the tongue depressor for 30 repetitions, 3 times per day, on 3 days of the 7-day week. For the tongue depressor group, they will be given 8 tongue depressors, which are disposable, for the duration of the study.

Also known as: Tongue Depressor

SOC

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 89 years old(inclusive)
• Diagnosis of Parkinson's Disease
• Hoen and Yahr stage II-IV
• Signs or symptoms of dysphagia evidenced by an EAT-10 score of 3 or more

You may not qualify if:

• Unwilling to sign the informed consent
• Atypical Parkinson's Disease, Parkinson Plus, Lewy Body Dementia, Multiple System Atrophy
• History of head or neck cancer
• History of seizures
• Current or past disorders of the jaw
• Allergy to device materials

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Davis Phinney Foundation: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Elizabeth Cuadrado

  Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort of 60 individuals with Parkinson's will be randomly assigned (please read 'Participant Randomization' below) to either exercise using the COSD or to standard of care using tongue depressors, as per the request of the funding source.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: March 15, 2023
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)