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Behavioural Intervention

COSD for Parkinson's Disease (COSD Trial)

N/A
Recruiting
Led By Elizabeth Cuadrado
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 8 weeks.
Awards & highlights

COSD Trial Summary

This trial is testing a new, low-cost device to see if it can increase tongue strength in people with Parkinson's disease. The device gives feedback on the person's tongue movement, similar to more expensive devices.

Who is the study for?
Adults aged 18-89 with Parkinson's Disease stages II-IV who have difficulty swallowing, as indicated by an EAT-10 score of at least 3. Participants must be able to give consent and not have atypical Parkinson's, other complex disorders like Lewy Body Dementia or Multiple System Atrophy, a history of head/neck cancer or seizures, jaw disorders, or allergies to the device materials.Check my eligibility
What is being tested?
The study is testing a new low-tech device called COSD against the standard tongue-strengthening exercises (SOC) using tongue depressors. The goal is to see if COSD can improve tongue strength for better chewing and swallowing in people with Parkinson’s disease.See study design
What are the potential side effects?
Since this trial involves non-invasive physical therapy equipment rather than medication, side effects may include discomfort in the mouth or jaw from using the devices but are expected to be minimal.

COSD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 8 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 8 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Tongue Strength, as measured in kPa via IOPI

COSD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: COSDExperimental Treatment1 Intervention
Participants assigned to the COSD, will use the investigational device.
Group II: SOCActive Control1 Intervention
Tongue depressors are the standard-of-care so the control group will use these instead of the investigational "Colorado Oral Strengthening Device."

Find a Location

Who is running the clinical trial?

Davis Phinney FoundationOTHER
4 Previous Clinical Trials
452 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,823 Total Patients Enrolled
Elizabeth CuadradoPrincipal InvestigatorDepartment of Otolaryngology

Media Library

Colorado Oral Strengthening Device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05464225 — N/A
Parkinson's Disease Research Study Groups: SOC, COSD
Parkinson's Disease Clinical Trial 2023: Colorado Oral Strengthening Device Highlights & Side Effects. Trial Name: NCT05464225 — N/A
Colorado Oral Strengthening Device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464225 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there prerequisites for enrollment in this medical experiment?

"This medical study is seeking 60 patients with parkinson disease of ages between 18 and 89. If a patient meets these criteria, they may be eligible for this trial."

Answered by AI

Does this clinical trial accommodate people under the age of 40?

"According to the criteria for inclusion, eligible patients must fall in between 18 and 89 years of age. There are currently 27 trials that focus on people younger than 18, as well as 487 intended for those over 65."

Answered by AI

Is there currently an opportunity for individuals to join this experiment?

"According to clinicaltrials.gov, this medical investigation is presently recruiting individuals; it was advertised on September 6th 2022 and had its details most recently revised also on that day."

Answered by AI

What is the size of the cohort involved in this experiment?

"Affirmative. According to data on clinicaltrials.gov, this medical trial is still in search of participants after first being posted on September 6th 2022 and last edited the same day. The investigative team requires 60 individuals across a single site for the duration of their study."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Colorado Oral Strengthening Device
2023. "Colorado Oral Strengthening Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05464225.
~7 spots leftby Jul 2024
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