Oropharyngeal DysphagiaNCT05325658
Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia
An observational study of Oropharyngeal Dysphagia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
Tasks of biomedical research: 1. To determine the severity of oropharyngeal dysphagia and the risk of aspiration in elderly patients. 2. To evaluate the quality of life of older patients with oropharyngeal dysphagia by performing validation of the Lithuanian version of the quality of life questionnaires in patients… Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- FEES, treatment with modified diet, electrical swallowing muscle stimulation.
- How many people
- 64 participants
- Where
- 1 siteLithuania
- Study dates
- 21 May 2021to 30 Sep 2023
- Phase
- Observational
- 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 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Geriatric patients treated at Kaunas Hospital who meet the inclusion criteria.
Who may be able to join
- Patients 60 years of age and older;
- Swallowing disorder suspected during hospitalization - oropharyngeal dysphagia;
- Patient's written consent.
Who cannot join
- severe oropharyngeal dysphagia (when feeding into the stomach through a nasogastric tube is required);
- Significant respiratory or heart failure: dyspnoea (respiratory rate> 20 rpm, SpO2 <90%), tachycardia (HR> 100 rpm);
- very severe malnutrition (severe exhaustion, severe signs of sarcopenia);
- final stage of oncological disease;
- severe dementia (Short Mental Test (MMSE) <10 points);
- Ingestion assessment with a fibroendoscope (FEES) did not reveal any swallowing problems (no dysphagia).
Trial locations and contacts
1 site in 1 country.
About this study
Tasks of biomedical research:
- To determine the severity of oropharyngeal dysphagia and the risk of aspiration in elderly patients.
- To evaluate the quality of life of older patients with oropharyngeal dysphagia by performing validation of the Lithuanian version of the quality of life questionnaires in patients with oropharyngeal dysphagia.
- To evaluate the severity of oropharyngeal dysphagia in elderly patients, the risk of aspiration, and quality of life after interventions.
Read more
Data on the sex, age and disease of the swallowing disorder will be collected. No processing of other personal data and health indicators is planned. All data will be collected in questionnaires. The data will be depersonalized by giving the patient a code.
The results and conclusions of the research will be described in the doctoral dissertation and will be used for scientific articles.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- FEES, treatment with modified diet, electrical swallowing muscle stimulation.
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEES, treatment with modified diet, electrical swallowing muscle stimulation.Other
Endoscopic swallowing assessment (FEES) consists of three parts:1) assessment of mouth, throat anatomy and more; 2) the patient is given to swallow a certain amount and consistency of liquids and solid food. 3) evaluated: preparation of the bolus for swallowing, aspiration. An 8-point Penetration-Aspiration scale is described.Swallowing exercises. Swallowing exercises are also used in practice, which can help coordinate the swallowing muscles or stimulate the nerves involved in the swallowing reflex.Transcutaneous electrical stimulation is a method of treating dysphagia in which weak electrical impulses stimulate the muscles in the neck area associated with swallowing. In patients with oropharyngeal dysphagia, patients have great difficulty swallowing water of normal consistency or other non-thick liquids, so they should be thickened with special thickeners to such an extent that the patient does not experience discomfort and be able to swallow.
| Study group | Role | What they receive |
|---|---|---|
| Oropharyngeal dysphagia | Patients with oropharyngeal dysphagia. Patients will be examined before and after combination therapy. Receives: Other: FEES, treatment with modified diet, electrical swallowing muscle stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle stimulation on swallowing function and quality of life in elderly patients with oropharyngeal dysphagia.
Primary outcomes focus on domains within reduction in the severity of oropharyngeal dysphagia and a reduction in the risk of aspiration after administration of a modified diet, electrical swallowing muscle stimulation and exercise to improve swallowing, after 10 days. The Penetration - Aspiration (J.C. Rosenbek et al., 1996) scale will be used before and after treatment to evaluate FEES. Assessing FEES: The higher the score, the more severe the disease.
Measured: 2021-2024
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle
Dysphagia Handicap Index (DHI): The higher the score, the more severe oropharyngeal dysphagia.
Measured: 2021-2024
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle
SWAL-QoL / SWAL-CARE: frequency scale (in questions 3, 5, 6, 9) and an evaluation scale (in questions 1, 2, 4, 7, 8), in the form of a 5-point Likert scale, where 1 corresponds to worst QoL and 5 to best QoL.
Measured: 2021-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start21 May 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Rugaitiene, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325658
- Sponsor's protocol ID
- 2.3
- Status last verified
- Jul 2024
- First submitted
- 29 Sep 2021
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT05325658
- Acronym / sponsor ID
- 2.3
- Conditions
- Oropharyngeal Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 13 Apr 2022 (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.
Tasks of biomedical research:
- To determine the severity of oropharyngeal dysphagia and the risk of aspiration in elderly patients.
- To evaluate the quality of life of older patients with oropharyngeal dysphagia by performing validation of the Lithuanian version of the quality of life questionnaires in patients with oropharyngeal dysphagia.
- To evaluate the severity of oropharyngeal dysphagia in elderly patients, the risk of aspiration, and quality of life after interventions.
Data on the sex, age and disease of the swallowing disorder will be collected. No processing of other personal data and health indicators is planned. All data will be collected in questionnaires. The data will be depersonalized by giving the patient a code.
The results and conclusions of the research will be described in the doctoral dissertation and will be used for scientific articles.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal dysphagia | – | Other: FEES, treatment with modified diet, electrical swallowing muscle stimulation.Patients with oropharyngeal dysphagia. Patients will be examined before and after combination therapy. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Geriatric patients treated at Kaunas Hospital who meet the inclusion criteria.
Key inclusion criteria (3 listed)
- Patients 60 years of age and older;
- Swallowing disorder suspected during hospitalization - oropharyngeal dysphagia;
- Patient's written consent.
Key exclusion criteria (6 listed)
- severe oropharyngeal dysphagia (when feeding into the stomach through a nasogastric tube is required);
- Significant respiratory or heart failure: dyspnoea (respiratory rate> 20 rpm, SpO2 <90%), tachycardia (HR> 100 rpm);
- very severe malnutrition (severe exhaustion, severe signs of sarcopenia);
- final stage of oncological disease;
- severe dementia (Short Mental Test (MMSE) <10 points);
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 |
|---|---|---|
| FEES, treatment with modified diet, electrical swallowing muscle stimulation.Endoscopic swallowing assessment (FEES) consists of three parts:1) assessment of mouth, throat anatomy and more; 2) the patient is given to swallow a certain amount and consistency of liquids and solid food. 3) evaluated: preparation of the bolus for swallowing, aspiration. An 8-point Penetration-Aspiration scale is described.Swallowing exercises. Swallowing exercises are also used in practice, which can help coordinate the swallowing muscles or stimulate the nerves involved in the swallowing reflex.Transcutaneous electrical stimulation is a method of treating dysphagia in which weak electrical impulses stimulate the muscles in the neck area associated with swallowing. In patients with oropharyngeal dysphagia, patients have great difficulty swallowing water of normal consistency or other non-thick liquids, so they should be thickened with special thickeners to such an extent that the patient does not experience discomfort and be able to swallow. | Other | Oropharyngeal dysphagia |
Primary outcome
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle stimulation on swallowing function and quality of life in elderly patients with oropharyngeal dysphagia.
Time frame: 2021-2024
Primary outcomes focus on domains within reduction in the severity of oropharyngeal dysphagia and a reduction in the risk of aspiration after administration of a modified diet, electrical swallowing muscle stimulation and exercise to improve swallowing, after 10 days. The Penetration - Aspiration (J.C. Rosenbek et al., 1996) scale will be used before and after treatment to evaluate FEES. Assessing FEES: The higher the score, the more severe the disease.
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle
Time frame: 2021-2024
Dysphagia Handicap Index (DHI): The higher the score, the more severe oropharyngeal dysphagia.
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle
Time frame: 2021-2024
SWAL-QoL / SWAL-CARE: frequency scale (in questions 3, 5, 6, 9) and an evaluation scale (in questions 1, 2, 4, 7, 8), in the form of a 5-point Likert scale, where 1 corresponds to worst QoL and 5 to best QoL.
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 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Dysphagia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 3 inclusion and 6 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 16 Jul 2024. 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 Lithuania. 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?
Evaluation of the influence of modified diet, exercise and electrical swallowing muscle stimulation on swallowing function and quality of life in elderly patients with oropharyngeal dysphagia. (time frame: 2021-2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024.