Deglutition DisordersNCT03494361
Evaluation of Dysphagia by 6-chnnel Surface Electromyography
An observational study of Deglutition Disorders, run by Seoul National University Hospital.
Trial summary
The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity. Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Deglutition Disorders
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2016to 21 Nov 2017
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: Healthy participants
Who may be able to join
- Age > 60, without dysphagia, comorbidity
- Age < 60, without dysphagia, comorbidity
Who cannot join
None listed.
About this study
Official title: Evaluation of Dysphagia by 6-chnnel Surface Electromyography and Preliminary Study for Design 6-channel Electrical Stimulation
The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity.
Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process.
First hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role.
Second hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food.
Read the detailed description
Inclusion criteria
Inclusion criteria of healthy older adults : Age > 60, without dysphagia, comorbidity
Inclusion criteria of young control group
: Age < 60, without dysphagia, comorbidity
No prior history of swallowing difficulty or history of central nervous system disease, and none were taking medication that are known to affect swallowing.
Surface EMG was performed at bilateral suprahyoid, thyrohyoid, sternothyroid and pharyngeal constrictors. The latency of activation and termination was checked.
- Conditions
- Deglutition Disorders
- Keywords
- deglutition disorders, electromyography
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young normal group | normal participants below 60 years | |
| Old normal group | normal participants above 60 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency
the latency of muscular activation
Measured: once at study, when patient enrolled
Secondary outcomes (1)
duration
the contractile duration of evaluated muscles
Measured: once at study, when patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start4 Jul 2016
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seok Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494361
- Sponsor's protocol ID
- B-1604/344-003
- Status last verified
- Jul 2020
- First submitted
- 2 Apr 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dysphagia by 6-chnnel Surface Electromyography and Preliminary Study for Design 6-channel Electrical Stimulation
- ClinicalTrials.gov ID
- NCT03494361
- Acronym / sponsor ID
- B-1604/344-003
- Conditions
- Deglutition Disorders
- Keywords
- deglutition disorders, electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 11 Apr 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 natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity.
Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process.
First hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role.
Second hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food.
Detailed description
Inclusion criteria
Inclusion criteria of healthy older adults : Age > 60, without dysphagia, comorbidity
Inclusion criteria of young control group
: Age < 60, without dysphagia, comorbidity
No prior history of swallowing difficulty or history of central nervous system disease, and none were taking medication that are known to affect swallowing.
Surface EMG was performed at bilateral suprahyoid, thyrohyoid, sternothyroid and pharyngeal constrictors. The latency of activation and termination was checked.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young normal group | – | –normal participants below 60 years |
| Old normal group | – | –normal participants above 60 years |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy participants
Key inclusion criteria (2 listed)
- Age > 60, without dysphagia, comorbidity
- Age < 60, without dysphagia, comorbidity
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Latency
Time frame: once at study, when patient enrolled
the latency of muscular activation
1 secondary outcome
duration
Time frame: once at study, when patient enrolled
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 23 Jul 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders, run by Seoul National University Hospital.
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 2 inclusion and 0 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Latency (time frame: once at study, when patient enrolled). 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 23 Jul 2020.