Colorado Oral Strengthening Device (COSD)
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COSD
SOC
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring tongue strength, novel exercise
Eligibility Criteria
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Colorado Anschutz Medical CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
COSD
SOC
Arm Description
Participants assigned to the COSD, will use the investigational device.
Tongue depressors are the standard-of-care so the control group will use these instead of the investigational "Colorado Oral Strengthening Device."
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05464225
First Posted
July 14, 2022
Last Updated
August 2, 2023
Sponsor
University of Colorado, Denver
Collaborators
Davis Phinney Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05464225
Brief Title
Colorado Oral Strengthening Device
Acronym
COSD
Official Title
Colorado Oral Strengthening Device
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Davis Phinney Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
tongue strength, novel exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COSD
Arm Type
Experimental
Arm Description
Participants assigned to the COSD, will use the investigational device.
Arm Title
SOC
Arm Type
Active Comparator
Arm Description
Tongue depressors are the standard-of-care so the control group will use these instead of the investigational "Colorado Oral Strengthening Device."
Intervention Type
Device
Intervention Name(s)
COSD
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SOC
Other Intervention Name(s)
Tongue Depressor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Tongue Strength, as measured in kPa via IOPI
Description
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.
Time Frame
Baseline, up to 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Cuadrado, MS, CCC-SLP
Phone
(740) 683-6907
Email
elizabeth.cuadrado@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ijeoma Eleazu, Pharm.D
Phone
(303) 724-6550
Email
ijeoma.eleazu@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Cuadrado
Organizational Affiliation
Department of Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Cuadrado, MS, CCC-SLP
Phone
303-724-7500
Email
elizabeth.cuadrado@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Ijeoma Eleazu, Pharm.D
Phone
(303) 724-6550
Email
ijeoma.eleazu@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Cuadrado, MS, CCC-SLP
First Name & Middle Initial & Last Name & Degree
Marie Jette, PhD, CCC-SLP
First Name & Middle Initial & Last Name & Degree
Matthew Clary, MD
First Name & Middle Initial & Last Name & Degree
Daniel S Fink, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Colorado Oral Strengthening Device
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