- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04082663
Dental Appliance for Parkinson's Disease (DAPD)
Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's
Study Overview
Detailed Description
The investigators are conducting a pilot study with participants who have been diagnosed with Parkinson disease recruited from the community. Participants will attend one in-person visit and be custom fitted with a dental mouthpiece. Participants will be asked to wear the mouthpiece as much as possible for one month including while sleeping and during the day, except while eating.
Participants will be asked to return for a second in-person visit to repeat gait and balance (motor) measures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine Program in Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- have a diagnosis of idiopathic, typical Parkinson Disease according to the United Kingdom Brain Bank Criteria, Hoehn & Yahr stages 1-3;
- stable Parkinson disease medications for the two weeks prior to baseline visit;
- be able to walk at least 10 meters at baseline with or without an assistive device;
- have their own teeth and/or dentures;
- be willing to try to wear a mouthpiece for one month;
- are over the age of 30; and
- provide written or verbal informed consent.
Exclusion Criteria:
- pre-existing medical conditions that would inhibit full participation in the study's tasks;
- absence of any dentition;
- cognitive impairments indicated by Mini Mental Status Exam (MMSE) score of <24;
- freezing of gait which moderately or severely impacts walking; or
- current use of an oral appliance (e.g., a dental mouthpiece, retainer, or braces).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dental Mouthpiece
Each participant will be fitted with a maxillary orthotic (mouthpiece).
The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans.
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Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit.
They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Gait Velocity
Time Frame: Baseline in-person visit
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Gait velocity will be measured while walking forwards with and without the mouthpiece
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Baseline in-person visit
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Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: Baseline in-person visit
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Balance will be measured with the Mini-Balance Evaluation Systems Test (Mini-BESTest) with and without the mouthpiece.
The assessment includes 14 items each of which is rated on a three-point scale (2: Normal, 1: Moderate, 0: Severe).
The 14 item scores are summed for a total score.
The range of scores is 0 to 28, and higher scores indicate better balance function.
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Baseline in-person visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Parkinson Disease Sleep Scale
Time Frame: Baseline and One month
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Indicators of sleep quality will be measured before and after wearing mouthpiece for one-month.
The visual analog scale has 15 commonly reported symptoms associated with sleep disturbance (e.g., overall quality of nights sleep, restlessness, daytime dozing).
Participants mark a cross along a 10 cm line labelled worst to best state.
Items are scored by measuring the distance along each line to the intersection with the cross in centimeters.
Each item score can range from 0 - symptom severe and always experienced to 10 - symptom-free.
The items are summed and the maximum cumulative score is 150 (free of all symptoms).
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Baseline and One month
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Changes in Parkinson Disease Questionnaire-39
Time Frame: Baseline and One month
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Quality of life will be measured before and after wearing mouthpiece for one-month.
This scale has 39 questions with 5 possible answers (0 = never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always).
There are eight dimensions: Mobility questions (q)1-10; Activities of Daily Living q11-16; Emotional well-being q17-22; Stigma q23-26; Social Support q27-29; Cognitive impairment q30-33; Communication q34-36; and Bodily Discomfort q37-39.
Dimensions are calculated on a scale of 0 to 100, 0 is no problem at all and 100 is maximum level of a problem.
The formula for scoring each dimension: (sum of scores of each question in dimension/4 (max.score per question) x nos.
questions in dimension)x100.
The formula for a total score (called single index) is sum of dimension scores/8.
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Baseline and One month
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Collaborators and Investigators
Investigators
- Principal Investigator: Gammon M Earhart, PhD, Washington University School of Medicine
Publications and helpful links
General Publications
- Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.
- Lane H, Rose LE, Woodbrey M, Arghavani D, Lawrence M, Cavanaugh JT. Exploring the Effects of Using an Oral Appliance to Reduce Movement Dysfunction in an Individual With Parkinson Disease: A Single-Subject Design Study. J Neurol Phys Ther. 2017 Jan;41(1):52-58. doi: 10.1097/NPT.0000000000000160.
- Potter K, Brandfass K. The Mini-Balance Evaluation Systems Test (Mini-BESTest). J Physiother. 2015 Oct;61(4):225. doi: 10.1016/j.jphys.2015.04.002. Epub 2015 Jun 1. No abstract available.
- Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10.
- Moeller DR. Evaluation of a Removable Intraoral Soft Stabilization Splint for the Reduction of Headaches and Nightmares in Military PTSD Patients: A Large Case Series. J Spec Oper Med. 2013 Spring;13(1):49-54.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201904098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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