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Interventions for Patients With Alzheimer's Disease and Dysphagia

Primary Purpose

Dementia, Dysphagia, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)
Biotene Oral Balance Gel
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Dysphagia, Alzheimer's Disease, Treatment, Lingual Strengthening, Saliva substitute

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria (patients):

  • Age 50-99
  • English speaking
  • Diagnosis of dementia or cognitive impairment or memory loss
  • Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0
  • Actively involved caregiver
  • Resides at home or an assisted living facility

Inclusion criteria (caregivers)

  • English speaking
  • Age 18 and older
  • Contact with patient at least 1 time a week
  • Has access to a working telephone

Exclusion criteria (patients):

  • Dementia due to cerebrovascular disease as primary cause
  • History of head and neck cancer or other structural deformity that can affect swallowing
  • Allergy to barium
  • Currently breastfeed or pregnant or planning to become pregnant

Exclusion criteria (caregivers):

  • Lacks ability to give consent

Sites / Locations

  • University of Wisconsin-MadisonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Usual care

Saliva Substitute Intervention

Lingual Strengthening Intervention

Saliva Substitute and Lingual Strengthening Intervention

Arm Description

Usual care groups will receive standard swallowing interventions identified by the Speech-Language Pathologist as appropriate to treat the patient's dysphagia and common in clinical practice. Such treatment would likely consist of dietary (e.g., thickened liquids or pureed foods) or postural compensatory strategies (e.g., chin down posture while swallowing). No progressive lingual strengthening approaches or regimented salivary substitute protocols are utilized.

Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied to the oral cavity regularly for 8 weeks.

Patient-caregiver dyads will be trained in the lingual strengthening protocol and patients will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device.

Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied regularly to the oral cavity for 8 weeks. Each dyad will also be trained in the lingual strengthening protocol and will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device.

Outcomes

Primary Outcome Measures

Change in Pharyngeal residue measured with the Normalized Residue Ratio Scale (NRRS)
Pixel-based measure of post-swallow pharyngeal barium residue as observed on a videofluoroscopic swallow study captured at 30 frames per second. This measure will represent the amount of pharyngeal residue as it relates to the distance between cervical vertebrae 2 and 4 which serve as an anatomical scalar. A higher value represents more pharyngeal residue which is a worse outcome.

Secondary Outcome Measures

Change in Modified Barium Swallow Impairment Profile (MBSImP) Overall Impairment Scores
Assessment of swallow function is completed though examination of 17 physiologic components requisite for the execution of normal swallowing. MBSImP includes an operationally defined scoring metric for each component that is applied to accurately describe and quantify progressing levels of impairment. Total possible range of scores is 0-62 with higher scores indicative of increased impairment.
Change in Penetration-Aspiration Scale Scores
The penetration-aspiration scale, a validated scale used to measure the severity of airway invasion with swallowing, will be used with recordings of videofluoroscopic swallow studies. This is an 8-point scale with no airway invasion represented by a score of 1 and aspiration with no response represented by a score of 8. A higher score represents a worse outcome.
Change in Lingual strength-maximal isometric lingual pressures
Maximum lingual pressures will be measured at the anterior and posterior locations of the tongue using the Iowa Oral Performance Instrument (IOPI). A higher value represents greater lingual pressure generation which is a better outcome.
Change in Functional Oral Intake Scale
This is a validated scale used the quantify the level of oral versus nonoral intake as well as any dietary modifications needed. A score of 1 represents no oral intake with complete dependence on a feeding tube while a score of 7 represents total oral intake with no diet modifications. A higher score represents a better outcome.
Change in Swallowing Quality of Life Questionnaire
The Swal-QOL is a validated questionnaire focused on swallowing-related quality of life. It comprises 10 multi-item scales, 2 general scales, and a 14-item symptom battery. Total possible range of scores is 0-100, higher scores represent better quality of life.
Change in Zarit Burden Interview
The Zarit Caregiver Burden Scale is used as a measure of caregiver psychological stress. The scores across all 22 items are summed and the range for the total score is from 0-88 with higher scores indicating greater burden (a worse outcome).
Change in Pneumonia diagnoses
As an exploratory outcome, we will review the electronic health record for all pneumonia diagnoses (ICD-10 codes)for 180 days after enrollment in the study. A decrease in the number of pneumonia diagnoses represents improvement.
Change in Salivary Production Rates
Saliva production will be quantified through weighing collection tubes before and after unstimulated and stimulated saliva collection. A higher saliva weight represents a greater salivary flow rate and more saliva production.
Change in Residual Mucosal Saliva (RMS)
RMS correlates with hyposalivation and dryness perception, will be collected from the anterior hard palate (AHP), anterior tongue (AT), and lower labial (LL) surfaces using SialoPaper strips (Oraflow Inc., Smithtown, NY, USA). These strips will be applied for 10 seconds and measured using Periotron device (Oraflow Inc.).

Full Information

First Posted
August 20, 2018
Last Updated
May 10, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03682081
Brief Title
Interventions for Patients With Alzheimer's Disease and Dysphagia
Official Title
Impact of Novel Rehabilitative Approaches for Dysphagia in Patients With Alzheimer's Disease and Related Dementias
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall purpose of this project is to develop effective dysphagia rehabilitative interventions for patients with Alzheimer's Disease and related dementias at risk for pneumonia development.
Detailed Description
This proposal consists of a small, randomized clinical trial to determine the impact of two novel interventions on swallowing-related outcomes in patients with mild-moderate Alzheimer's Disease and Related Dementias (ADRD) and identify subgroups of patients most likely to benefit from these interventions. Patient-caregiver dyads will be randomized to lingual strengthening, saliva substitute use, a combination of the two, or only usual care. Saliva and swallowing-related outcomes will be collected at baseline and following the 8 week intervention period. Consent and Randomization: Eligible dyads will be approached, consented and randomized at clinical care sites within University of Wisconsin Hospital and Clinics. Eligible participants' capacity to consent will determined by their primary clinical provider or team. Research staff will consent participant (or legally authorized representatives) prior to their swallow study. Each dyad will have equal chances of randomization to either usual care or one of the intervention arms plus usual care, with randomization stratified by the participant's dementia severity determined by the Clinical Dementia Rating (CDR) scale to ensure equal distribution of mild and moderate patients. Baseline Assessment: Following randomization, the baseline assessment will be completed in tandem with the outpatient clinic visit. Staff will collect data on sociodemographics, comorbidities (using the Charlson comorbidity score approach) and medications (including anticholinergics and neuroleptics). The Montreal Cognitive Assessment (MoCA) will be administered at this time. Oral health status will be graded using the Brief Oral Health Status Examination, a valid and reliable scoring instrument developed for non-dental health care providers in long term care. Dentition will be characterized by the number of posterior occlusal pairs of teeth and denture use. Smoking history and active use during the study will be recorded. Usual Care: Usual care group participants will receive standard swallowing interventions as recommended by the clinical Speech-Language Pathologist. Such treatment would likely consist of dietary (e.g., thickened liquids or pureed foods) or postural compensatory strategies (e.g., chin down posture while swallowing). All patient participants in intervention groups will also receive usual care, as indicated per their primary clinical team. Interventions: Saliva substitute: Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel. Participants will be instructed to apply an amount equivalent to about 1 cm of gel with a finger to the tongue and most intensely affected areas of the oral cavity three times a day for 8 weeks. Caregivers will be trained in how to assist the patient with application and support will be provided through follow-up phone calls. Lingual strengthening intervention: Device training for dyads assigned to lingual strengthening will occur following randomization during the research visit. Isometric tongue strengthening will be completed using the Iowa Oral Performance Instrument (IOPI) over an 8-week program. An air-filled pressure bulb is placed on the surface of the oral tongue and pressed against the hard palate during exercise. Each patient is given a target pressure value to aim for as determined by the baseline one repetition maximum (1RM) lingual pressures. During week one of the regimen, the target value of each repetition will be 60% of the 1RM. For the remaining seven weeks, the target value will be increased to 80% of the 1RM. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated. The final assessment point will be after completion of lingual strengthening. Training will be provided to both participants and caregivers on the device and lingual strengthening protocol and support will be provided to dyads through follow-up phone calls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Dysphagia, Alzheimer Disease
Keywords
Dementia, Dysphagia, Alzheimer's Disease, Treatment, Lingual Strengthening, Saliva substitute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care groups will receive standard swallowing interventions identified by the Speech-Language Pathologist as appropriate to treat the patient's dysphagia and common in clinical practice. Such treatment would likely consist of dietary (e.g., thickened liquids or pureed foods) or postural compensatory strategies (e.g., chin down posture while swallowing). No progressive lingual strengthening approaches or regimented salivary substitute protocols are utilized.
Arm Title
Saliva Substitute Intervention
Arm Type
Experimental
Arm Description
Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied to the oral cavity regularly for 8 weeks.
Arm Title
Lingual Strengthening Intervention
Arm Type
Experimental
Arm Description
Patient-caregiver dyads will be trained in the lingual strengthening protocol and patients will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device.
Arm Title
Saliva Substitute and Lingual Strengthening Intervention
Arm Type
Experimental
Arm Description
Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied regularly to the oral cavity for 8 weeks. Each dyad will also be trained in the lingual strengthening protocol and will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device.
Intervention Type
Device
Intervention Name(s)
Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)
Other Intervention Name(s)
Tongue strengthening
Intervention Description
An air-filled pressure bulb is placed on the surface of the oral tongue and pressed against the hard palate during exercise. Each patient is given a target pressure value to aim for as determined by the baseline one repetition maximum (1RM) lingual pressures. During week one of the regimen, the target value of each repetition will be 60% of the 1RM. For the remaining seven weeks, the target value will be increased to 80% of the 1RM. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated.
Intervention Type
Device
Intervention Name(s)
Biotene Oral Balance Gel
Other Intervention Name(s)
Saliva substitute
Intervention Description
Participants will be instructed to apply an amount equivalent to about 1 cm of Biotene® Oral Balance Gel with a finger to the tongue and most intensely affected areas of the oral cavity three times a day after brushing their teeth for 8 weeks.
Primary Outcome Measure Information:
Title
Change in Pharyngeal residue measured with the Normalized Residue Ratio Scale (NRRS)
Description
Pixel-based measure of post-swallow pharyngeal barium residue as observed on a videofluoroscopic swallow study captured at 30 frames per second. This measure will represent the amount of pharyngeal residue as it relates to the distance between cervical vertebrae 2 and 4 which serve as an anatomical scalar. A higher value represents more pharyngeal residue which is a worse outcome.
Time Frame
Baseline, Post-treatment at approximately 8 weeks
Secondary Outcome Measure Information:
Title
Change in Modified Barium Swallow Impairment Profile (MBSImP) Overall Impairment Scores
Description
Assessment of swallow function is completed though examination of 17 physiologic components requisite for the execution of normal swallowing. MBSImP includes an operationally defined scoring metric for each component that is applied to accurately describe and quantify progressing levels of impairment. Total possible range of scores is 0-62 with higher scores indicative of increased impairment.
Time Frame
Baseline, Post-treatment at approximately 8 weeks
Title
Change in Penetration-Aspiration Scale Scores
Description
The penetration-aspiration scale, a validated scale used to measure the severity of airway invasion with swallowing, will be used with recordings of videofluoroscopic swallow studies. This is an 8-point scale with no airway invasion represented by a score of 1 and aspiration with no response represented by a score of 8. A higher score represents a worse outcome.
Time Frame
Baseline, Post-treatment at approximately 8 weeks
Title
Change in Lingual strength-maximal isometric lingual pressures
Description
Maximum lingual pressures will be measured at the anterior and posterior locations of the tongue using the Iowa Oral Performance Instrument (IOPI). A higher value represents greater lingual pressure generation which is a better outcome.
Time Frame
Baseline, Post-treatment at approximately 8 weeks
Title
Change in Functional Oral Intake Scale
Description
This is a validated scale used the quantify the level of oral versus nonoral intake as well as any dietary modifications needed. A score of 1 represents no oral intake with complete dependence on a feeding tube while a score of 7 represents total oral intake with no diet modifications. A higher score represents a better outcome.
Time Frame
Baseline, Post-treatment at approximately 8 weeks
Title
Change in Swallowing Quality of Life Questionnaire
Description
The Swal-QOL is a validated questionnaire focused on swallowing-related quality of life. It comprises 10 multi-item scales, 2 general scales, and a 14-item symptom battery. Total possible range of scores is 0-100, higher scores represent better quality of life.
Time Frame
Baseline, Post-treatment at approximately 8 weeks.
Title
Change in Zarit Burden Interview
Description
The Zarit Caregiver Burden Scale is used as a measure of caregiver psychological stress. The scores across all 22 items are summed and the range for the total score is from 0-88 with higher scores indicating greater burden (a worse outcome).
Time Frame
Baseline, Post-treatment at approximately 8 weeks
Title
Change in Pneumonia diagnoses
Description
As an exploratory outcome, we will review the electronic health record for all pneumonia diagnoses (ICD-10 codes)for 180 days after enrollment in the study. A decrease in the number of pneumonia diagnoses represents improvement.
Time Frame
Post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180
Title
Change in Salivary Production Rates
Description
Saliva production will be quantified through weighing collection tubes before and after unstimulated and stimulated saliva collection. A higher saliva weight represents a greater salivary flow rate and more saliva production.
Time Frame
Baseline, Post-treatment at approximately 8 weeks
Title
Change in Residual Mucosal Saliva (RMS)
Description
RMS correlates with hyposalivation and dryness perception, will be collected from the anterior hard palate (AHP), anterior tongue (AT), and lower labial (LL) surfaces using SialoPaper strips (Oraflow Inc., Smithtown, NY, USA). These strips will be applied for 10 seconds and measured using Periotron device (Oraflow Inc.).
Time Frame
Baseline, Post-treatment at approximately 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria (patients): Age 50-99 English speaking Diagnosis of dementia or cognitive impairment or memory loss Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0 Actively involved caregiver Resides at home or an assisted living facility Inclusion criteria (caregivers) English speaking Age 18 and older Contact with patient at least 1 time a week Has access to a working telephone Exclusion criteria (patients): Dementia due to cerebrovascular disease as primary cause History of head and neck cancer or other structural deformity that can affect swallowing Allergy to barium Currently breastfeed or pregnant or planning to become pregnant Exclusion criteria (caregivers): Lacks ability to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Gustafson, MS, CCC-SLP
Phone
608-262-9995
Email
segustafson@wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith Mackowicz-Torres, MS, CCC-SLP
Phone
608-262-9995
Email
mackowicz@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Rogus-Pulia, PhD, CCC-SLP
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Gustafson, MS, CCC-SLP
Phone
608-262-9995
Email
segustafson@wisc.edu
First Name & Middle Initial & Last Name & Degree
Meredith Mackowicz-Torres, CCC-SLP
Phone
608-262-9995
Email
mackowicz@wisc.edu
First Name & Middle Initial & Last Name & Degree
Nicole Rogus-Pulia, PhD, CCC-SLP

12. IPD Sharing Statement

Plan to Share IPD
No
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Interventions for Patients With Alzheimer's Disease and Dysphagia

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