Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interventions for Patients With Alzheimer's Disease and Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682081
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Dementia Dysphagia Alzheimer Disease Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) Device: Biotene Oral Balance Gel Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Novel Rehabilitative Approaches for Dysphagia in Patients With Alzheimer's Disease
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023


Arm Intervention/treatment
No Intervention: Usual care
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.
Experimental: Saliva Substitute Intervention
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.
Device: Biotene Oral Balance Gel
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.
Other Name: Saliva substitute

Experimental: Lingual Strengthening Intervention
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.
Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)
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.
Other Name: Tongue strengthening

Experimental: Saliva Substitute and Lingual Strengthening Intervention
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.
Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)
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.
Other Name: Tongue strengthening

Device: Biotene Oral Balance Gel
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.
Other Name: Saliva substitute




Primary Outcome Measures :
  1. Change in Pharyngeal residue measured with the Normalized Residue Ratio Scale (NRRS) [ Time Frame: Baseline, Post-treatment at approximately 8 weeks ]
    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 :
  1. Change in Modified Barium Swallow Impairment Profile (MBSImP) Overall Impairment Scores [ Time Frame: Baseline, Post-treatment at approximately 8 weeks ]
    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.

  2. Change in Penetration-Aspiration Scale Scores [ Time Frame: Baseline, Post-treatment at approximately 8 weeks ]
    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.

  3. Change in Lingual strength-maximal isometric lingual pressures [ Time Frame: Baseline, Post-treatment at approximately 8 weeks ]
    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.

  4. Change in Functional Oral Intake Scale [ Time Frame: Baseline, Post-treatment at approximately 8 weeks ]
    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.

  5. Change in Swallowing Quality of Life Questionnaire [ Time Frame: Baseline, Post-treatment at approximately 8 weeks. ]
    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.

  6. Change in Zarit Burden Interview [ Time Frame: Baseline, Post-treatment at approximately 8 weeks ]
    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).

  7. Change in Pneumonia diagnoses [ Time Frame: Post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180 ]
    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.

  8. Change in Salivary Quantity and viscoelasticity [ Time Frame: Baseline, Post-treatment at approximately 8 weeks ]
    Saliva production will be quantified through weighing collection tubes before and after unstimulated and stimulated saliva collection over a 5 minute time frame. A higher saliva weight represents a greater salivary flow rate and more saliva production.

  9. Change in Salivary Viscoelasticity [ Time Frame: Baseline, Post-treatment at approximately 8 weeks ]
    Saliva production will be quantified through weighing collection tubes before and after unstimulated and stimulated saliva collection over a 5 minute time frame. Saliva viscoelasticity will be measured using a HAAKE CaBER 1 capillary extensional rheometer. A higher viscoelasticity value represents thicker saliva which is likely a worse outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria (patients):

  • Non-hospice inpatient or outpatient seen at University of Wisconsin Hospitals and Clinics
  • English speaking
  • age 55-99
  • Diagnosis of dementia or cognitive impairment or memory loss
  • Referral for a videofluoroscopic swallow study
  • Actively involved caregiver
  • Resides at home or an assisted living facility
  • Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0

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):

  • Discharged to institutional settings (e.g., other hospitals, skilled nursing facilities, long-term care centers)
  • Discharged to hospice
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682081


Contacts
Layout table for location contacts
Contact: Vanessa Cannaday, MS 608-263-1344 vcannaday@wisc.edu
Contact: Sara Gustafson, MS, CCC-SLP 608-262-9995 segustafson@wisc.edu

Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Vanessa Cannaday, MS    608-263-1344    vcannaday@wisc.edu   
Contact: Sara Gustafson, MS, CCC-SLP    608-262-9995    segustafson@wisc.edu   
Principal Investigator: Nicole Rogus-Pulia, PhD, CCC-SLP         
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Nicole Rogus-Pulia, PhD, CCC-SLP University of Wisconsin, Madison
Publications:
Rogus-Pulia N, Malandraki GA, Johnson S, & Robbins J. (2015). Understanding Dysphagia in dementia: The present and the future. Current Physical Medicine and Rehabilitation Reports, 3(1), 86-97.
FastStats - Alzheimers Disease. https://www.cdc.gov/nchs/fastats/alzheimers.htm. Accessed February 11, 2017.
Borson S, Lampe T, Raskind M, Veith R, Morely J, Coe R, et al. (1992). Autonomic nervous system dysfunction in Alzheimer's disease: Implications for pathophysiology and treatment. Memory Function in Aging and Age-Related Disorders. New York: Springer Verlag, 175-189.
Robison R. (2015). The Impact of Lingual Resistance Training in Two Individuals with Amyotrophic Lateral Sclerosis: A Case Series. University of South Florida Scholar Commons.
Winchester J, & Winchester C. (2015). Cognitive dysphagia and effectively managing the five systems. Perspectives of the American Speech-Language-Hearing Association Special Interest Groups, 20.
R Core Team. (2016). R: A Language and Environment for Statistical Computing. http://www.cran.rproject.org/package=ordinal/.
Christensen RHB. (2015). Ordinal- Regression Models for Ordinal Data: R package version 2015.6-28.
Bertrand F, Meyer N, & Maumy-Bertrand M. (2014). Partial Least Squares Regression for Generalized Linear Models: R package version 1.1.1.

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03682081    
Other Study ID Numbers: 2018-0835
A534255 ( Other Identifier: UW Madison )
SMPH/MEDICINE/GER-AD DEV ( Other Identifier: UW Madison )
1K23AG057805-01A1 ( U.S. NIH Grant/Contract )
Protocol Version 3, 10/29/2019 ( Other Identifier: UW Madison )
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by University of Wisconsin, Madison:
Dementia
Dysphagia
Alzheimer's Disease
Treatment
Lingual Strengthening
Saliva substitute
Additional relevant MeSH terms:
Layout table for MeSH terms
Deglutition Disorders
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases