DementiaNCT03682081
Interventions for Patients With Alzheimer's Disease and Dysphagia
A study testing Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) and Biotene Oral Balance Gel in people with Dementia and Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Dementia, Dysphagia, Alzheimer Disease
- What is being tested?
- Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) and Biotene Oral Balance Gel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2020to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, assisted living facility, or long-term care facility
Show all 10Show fewer
- English speaking
- Age 18 and older
- Contact with patient at least 1 time a week
- Has access to a working telephone
Who cannot join
- 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
- Lacks ability to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
Official title: Impact of Novel Rehabilitative Approaches for Dysphagia in Patients With Alzheimer's Disease and Related Dementias
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.
Read the 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.
- Conditions
- Dementia, Dysphagia, Alzheimer Disease
- Being tested
- Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI), Biotene Oral Balance Gel
- Keywords
- Dementia, Dysphagia, Alzheimer's Disease, Treatment, Lingual Strengthening, Saliva substitute
- Medical subject headings
- Dementia, Deglutition Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)Device
Also called Tongue strengthening
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.
Biotene Oral Balance GelDevice
Also called Saliva substitute
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | 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. |
| Saliva Substitute Intervention | Experimental | 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. Receives: Device: Biotene Oral Balance Gel |
| Lingual Strengthening Intervention | Experimental | 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. Receives: Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) |
| Saliva Substitute and Lingual Strengthening Intervention | Experimental | 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. Receives: Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI); Device: Biotene Oral Balance Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Pharyngeal Residue between C2-C4
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 (C2-C4) which serve as an anatomical scalar. A higher value represents more pharyngeal residue which is a worse outcome.
Measured: Baseline, Post-treatment at approximately 8 weeks
Secondary outcomes (9)
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.
Measured: Baseline, Post-treatment at approximately 8 weeks
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.
Measured: Baseline, Post-treatment at approximately 8 weeks
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.
Measured: Baseline, Post-treatment at approximately 8 weeks
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.
Measured: Baseline, Post-treatment at approximately 8 weeks
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.
Measured: Baseline, Post-treatment at approximately 8 weeks.
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).
Measured: Baseline, Post-treatment at approximately 8 weeks
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.
Measured: Baseline, Post-treatment at approximately 8 weeks
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.).
Measured: Baseline, Post-treatment at approximately 8 weeks
Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scores
Assessment of swallow function is completed though analysis of videofluoroscopic images for swallowing safety and efficiency with the DIGEST tool. This is a validated method for identifying and rating penetration, aspiration, and residue, resulting in an overall score. DIGEST scores combine an evaluation of individual swallows to determine a safety grade of 0-4 with an efficiency grade of 0-4 to determine an overall DIGEST grade of 0 (no impairment) to 4 (profound impairment).
Measured: Baseline, Post-treatment at approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start25 Sep 2020
- Primary completion30 Aug 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (95)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Nicole Rogus-Pulia, PhD, CCC-SLP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682081
- Sponsor's protocol ID
- 2018-0835
- Other IDs
- A534255, SMPH/MEDICINE/GER-AD DEV, K76AG068590, Protocol Version 5/21/2024
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2018
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
Foley NC, Affoo RH, Martin RE. A systematic review and meta-analysis examining pneumonia-associated mortality in dementia. Dement Geriatr Cogn Disord. 2015;39(1-2):52-67. doi: 10.1159/000367783. Epub 2014 Oct 22.
PubMed 25342272Alagiakrishnan K, Bhanji RA, Kurian M. Evaluation and management of oropharyngeal dysphagia in different types of dementia: a systematic review. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):1-9. doi: 10.1016/j.archger.2012.04.011. Epub 2012 May 19.
PubMed 22608838Kuroda Y. Factors associated with the level of oral intake in hospitalized older adults with dysphagia: The importance of mental activity. Clin Nutr ESPEN. 2016 Jun;13:e52-e54. doi: 10.1016/j.clnesp.2016.03.001. Epub 2016 Mar 27.
PubMed 28531569Riviere S, Gillette-Guyonnet S, Andrieu S, Nourhashemi F, Lauque S, Cantet C, Salva A, Frisoni G, Vellas B. Cognitive function and caregiver burden: predictive factors for eating behaviour disorders in Alzheimer's disease. Int J Geriatr Psychiatry. 2002 Oct;17(10):950-5. doi: 10.1002/gps.724.
PubMed 12325056Brunnstrom HR, Englund EM. Cause of death in patients with dementia disorders. Eur J Neurol. 2009 Apr;16(4):488-92. doi: 10.1111/j.1468-1331.2008.02503.x.
PubMed 19170740Wada H, Nakajoh K, Satoh-Nakagawa T, Suzuki T, Ohrui T, Arai H, Sasaki H. Risk factors of aspiration pneumonia in Alzheimer's disease patients. Gerontology. 2001 Sep-Oct;47(5):271-6. doi: 10.1159/000052811.
PubMed 11490146Milte R, Shulver W, Killington M, Bradley C, Miller M, Crotty M. Struggling to maintain individuality - Describing the experience of food in nursing homes for people with dementia. Arch Gerontol Geriatr. 2017 Sep;72:52-58. doi: 10.1016/j.archger.2017.05.002. Epub 2017 May 17.
PubMed 28552702Horner J, Alberts MJ, Dawson DV, Cook GM. Swallowing in Alzheimer's disease. Alzheimer Dis Assoc Disord. 1994 Fall;8(3):177-89. doi: 10.1097/00002093-199408030-00004.
PubMed 7986487Volicer L, Seltzer B, Rheaume Y, Karner J, Glennon M, Riley ME, Crino P. Eating difficulties in patients with probable dementia of the Alzheimer type. J Geriatr Psychiatry Neurol. 1989 Oct-Dec;2(4):188-95. doi: 10.1177/089198878900200404.
PubMed 2483945Easterling CS, Robbins E. Dementia and dysphagia. Geriatr Nurs. 2008 Jul-Aug;29(4):275-85. doi: 10.1016/j.gerinurse.2007.10.015.
PubMed 18694703Correia Sde M, Morillo LS, Jacob Filho W, Mansur LL. Swallowing in moderate and severe phases of Alzheimer's disease. Arq Neuropsiquiatr. 2010 Dec;68(6):855-61. doi: 10.1590/s0004-282x2010000600005.
PubMed 21243241Secil Y, Arici S, Incesu TK, Gurgor N, Beckmann Y, Ertekin C. Dysphagia in Alzheimer's disease. Neurophysiol Clin. 2016 Jun;46(3):171-8. doi: 10.1016/j.neucli.2015.12.007. Epub 2016 May 11.
PubMed 26924307Sakai K, Hirano H, Watanabe Y, Tohara H, Sato E, Sato K, Katakura A. An examination of factors related to aspiration and silent aspiration in older adults requiring long-term care in rural Japan. J Oral Rehabil. 2016 Feb;43(2):103-10. doi: 10.1111/joor.12349. Epub 2015 Oct 3.
PubMed 26432521Logemann JA, Gensler G, Robbins J, Lindblad AS, Brandt D, Hind JA, Kosek S, Dikeman K, Kazandjian M, Gramigna GD, Lundy D, McGarvey-Toler S, Miller Gardner PJ. A randomized study of three interventions for aspiration of thin liquids in patients with dementia or Parkinson's disease. J Speech Lang Hear Res. 2008 Feb;51(1):173-83. doi: 10.1044/1092-4388(2008/013).
PubMed 18230864
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Novel Rehabilitative Approaches for Dysphagia in Patients With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT03682081
- Acronym / sponsor ID
- 2018-0835
- Conditions
- Dementia, Dysphagia, Alzheimer Disease
- Keywords
- Dementia, Dysphagia, Alzheimer's Disease, Treatment, Lingual Strengthening, Saliva substitute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –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. |
| Saliva Substitute Intervention | Experimental | Device: Biotene Oral Balance GelEach 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. |
| Lingual Strengthening Intervention | Experimental | Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)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. |
| Saliva Substitute and Lingual Strengthening Intervention | Experimental | Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI), Device: Biotene Oral Balance GelEach 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. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Lacks ability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)Also: Tongue strengtheningAn 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. | Device | Lingual Strengthening Intervention, Saliva Substitute and Lingual Strengthening Intervention |
| Biotene Oral Balance GelAlso: Saliva substituteParticipants 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. | Device | Saliva Substitute Intervention, Saliva Substitute and Lingual Strengthening Intervention |
Primary outcome
Percentage Pharyngeal Residue between C2-C4
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 (C2-C4) which serve as an anatomical scalar. A higher value represents more pharyngeal residue which is a worse outcome.
9 secondary outcomes
Change in Modified Barium Swallow Impairment Profile (MBSImP) Overall Impairment Scores
Time frame: Baseline, Post-treatment at approximately 8 weeks
Change in Penetration-Aspiration Scale Scores
Time frame: Baseline, Post-treatment at approximately 8 weeks
Change in Lingual strength-maximal isometric lingual pressures
Time frame: Baseline, Post-treatment at approximately 8 weeks
Change in Functional Oral Intake Scale
Time frame: Baseline, Post-treatment at approximately 8 weeks
Change in Swallowing Quality of Life Questionnaire
Time frame: Baseline, Post-treatment at approximately 8 weeks.
Change in Zarit Burden Interview
Time frame: Baseline, Post-treatment at approximately 8 weeks
Change in Salivary Production Rates
Time frame: Baseline, Post-treatment at approximately 8 weeks
Change in Residual Mucosal Saliva (RMS)
Time frame: Baseline, Post-treatment at approximately 8 weeks
Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scores
Time frame: Baseline, Post-treatment at approximately 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- BackgroundRogus-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.
- Background: PubMed 25342272Foley NC, Affoo RH, Martin RE. A systematic review and meta-analysis examining pneumonia-associated mortality in dementia. Dement Geriatr Cogn Disord. 2015;39(1-2):52-67. doi: 10.1159/000367783. Epub 2014 Oct 22.
- Background: PubMed 22608838Alagiakrishnan K, Bhanji RA, Kurian M. Evaluation and management of oropharyngeal dysphagia in different types of dementia: a systematic review. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):1-9. doi: 10.1016/j.archger.2012.04.011. Epub 2012 May 19.
- Background: PubMed 28531569Kuroda Y. Factors associated with the level of oral intake in hospitalized older adults with dysphagia: The importance of mental activity. Clin Nutr ESPEN. 2016 Jun;13:e52-e54. doi: 10.1016/j.clnesp.2016.03.001. Epub 2016 Mar 27.
- Background: PubMed 12325056Riviere S, Gillette-Guyonnet S, Andrieu S, Nourhashemi F, Lauque S, Cantet C, Salva A, Frisoni G, Vellas B. Cognitive function and caregiver burden: predictive factors for eating behaviour disorders in Alzheimer's disease. Int J Geriatr Psychiatry. 2002 Oct;17(10):950-5. doi: 10.1002/gps.724.
- Background: PubMed 19170740Brunnstrom HR, Englund EM. Cause of death in patients with dementia disorders. Eur J Neurol. 2009 Apr;16(4):488-92. doi: 10.1111/j.1468-1331.2008.02503.x.
- Background: PubMed 11490146Wada H, Nakajoh K, Satoh-Nakagawa T, Suzuki T, Ohrui T, Arai H, Sasaki H. Risk factors of aspiration pneumonia in Alzheimer's disease patients. Gerontology. 2001 Sep-Oct;47(5):271-6. doi: 10.1159/000052811.
- Background: PubMed 28552702Milte R, Shulver W, Killington M, Bradley C, Miller M, Crotty M. Struggling to maintain individuality - Describing the experience of food in nursing homes for people with dementia. Arch Gerontol Geriatr. 2017 Sep;72:52-58. doi: 10.1016/j.archger.2017.05.002. Epub 2017 May 17.
- Background: PubMed 7986487Horner J, Alberts MJ, Dawson DV, Cook GM. Swallowing in Alzheimer's disease. Alzheimer Dis Assoc Disord. 1994 Fall;8(3):177-89. doi: 10.1097/00002093-199408030-00004.
- Background: PubMed 2483945Volicer L, Seltzer B, Rheaume Y, Karner J, Glennon M, Riley ME, Crino P. Eating difficulties in patients with probable dementia of the Alzheimer type. J Geriatr Psychiatry Neurol. 1989 Oct-Dec;2(4):188-95. doi: 10.1177/089198878900200404.
- Background: PubMed 18694703Easterling CS, Robbins E. Dementia and dysphagia. Geriatr Nurs. 2008 Jul-Aug;29(4):275-85. doi: 10.1016/j.gerinurse.2007.10.015.
- Background: PubMed 21243241Correia Sde M, Morillo LS, Jacob Filho W, Mansur LL. Swallowing in moderate and severe phases of Alzheimer's disease. Arq Neuropsiquiatr. 2010 Dec;68(6):855-61. doi: 10.1590/s0004-282x2010000600005.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Rogus-Pulia, PhD, CCC-SLP principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) and Biotene Oral Balance Gel in people with Dementia and Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Pharyngeal Residue between C2-C4 (time frame: Baseline, Post-treatment at approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682081, which also lists 95 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.