Image

Colorado Oral Strengthening Device

Recruiting
18 - 89 years of age
Both
Phase N/A

Powered by AI

Overview

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.

Description

When an individual contacts the PI or the department research coordinator, a preliminary screen will be administered for any obvious exclusion. If there are no exclusions, the first visit will be scheduled. At this initial visit, a full description of the study and exercise protocol will be provided. A health history questionnaire and an EAT-10 questionnaire will be administered.

If consent is obtained, baseline tongue strength will be measured using the IOPI device. Individuals with Parkinson's will be randomized to exercise with the COSD or with the tongue depressors. Those who will use the COSD will be start with no less than 60% max strength and receive an exercise log. Those using the tongue depressors will also receive an exercise log.

All participants will receive a full demonstration of the exercise and will be asked to return the demonstration.

The second visit will be scheduled for all participants the following week. At that time, the EAT-10 and tongue strength will be re-assessed. The exercise logs will be reviewed to ensure compliance. Participants using the COSD will be issued a new device that is no less than 80% of their max strength.

The third visit will be scheduled the following week (week 3). The EAT-10 questionnaire and tongue strength will be reassessed. The exercise log will be reviewed for compliance. COSD will be inspected for any signs of wear and a new one will be issued if the device appears worn.

The last 2 visits will be scheduled during weeks 6 and 8 of the exercise protocol. The EAT-10 and tongue strength will be re-assessed, and the exercise log will be reviewed for compliance. The COSD will be inspected for any signs of wear and a new one will be issued if the device appears worn. In addition, during the final visit, all participants will be asked to complete a questionnaire regarding their satisfaction with the exercise device they were assigned. The COSD will be collected at that visit.

Eligibility

Inclusion Criteria:

  1. 18 to 89 years old(inclusive)
  2. Diagnosis of Parkinson's Disease
  3. Hoen and Yahr stage II-IV
  4. Signs or symptoms of dysphagia evidenced by an EAT-10 score of 3 or more

Exclusion Criteria:

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

Study details

Parkinson Disease

NCT05464225

University of Colorado, Denver

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.