Swallowing DisorderNCT06411236
Functional Response Characteristics of Brain Under Swallowing Task Paradigm
An observational study of Swallowing Disorder and Dysphagia, run by Ruyao Liu at 1 site in China.
Trial summary
Functional near-infrared spectroscopy was used to investigate the cortical activation patterns and lateralization during swallowing tasks in 15 healthy middle-aged and elderly people and 15 healthy young people. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Swallowing Disorder, Dysphagia, Swallowing Substances
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 10 Dec 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People aged 18-25 who met the inclusion exclusion criteria were included in the younger group. People aged 50-70 who met the exclusion criteria were included in the Middle aged group.Subjects need to understand the swallowing task and cooperate well.
Who may be able to join
- Middle and old age group: 50~70 years old; Young group: 18~25 years old; Right-handed; No history of neurological, psychiatric, respiratory, or swallowing dysfunction; No brain injury, epilepsy, head and neck disease, gastroesophageal reflux disease; No cases of skull defect, head infection and skin damage that could not be detected by function near-infrared spectroscopy; Subjects signed informed consent forms in accordance with the Declaration of Helsinki.
- -
Who cannot join
- pregnancy; poor patient compliance and non-cooperation with evaluation.
- -
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan, 450000
About this study
Official title: Functional Response Characteristics of Brain Under Swallowing Task Paradigm Based on Functional Near-infrared Spectroscopy
Functional near-infrared spectroscopy was used to investigate the cortical activation patterns and lateralization during swallowing tasks in 15 healthy middle-aged and elderly people and 15 healthy young people. It provides a theoretical basis for the study of swallowing function and a new idea for the treatment of patients with swallowing disorders.
Read the detailed description
Swallowing is coordinated by hyoid muscle group, pharyngeal muscle and upper esophageal muscle, as well as the regulation of swallowing related functional brain area. Dysphagia refers to the inability to safely and effectively transport food from the mouth to the stomach to obtain adequate nutrition and water, resulting in eating difficulties. Studies have shown that swallowing disorders are mainly caused by stroke, brain trauma, neurodegenerative diseases (Alzheimer's disease, Parkinson's disease, multiple sclerosis and amyotrophic lateral sclerosis) and head and neck cancers (oral tumors, nasopharyngeal and laryngeal cancers). Moreover, the prevalence of dysphagia increases with age. Patients with dysphagia often have many complications, which may lead to dehydration, malnutrition, aspiration, pneumonia, etc., which greatly delays the recovery process of patients and reduces the quality of life of patients. Studies have shown that the swallowing network includes multiple brain regions, including the primary somatosensory cortex, primary motor cortex, bilateral premotor and auxiliary motor cortex, cingulate cortex, prefrontal, temporal, precuneus, subparietal lobule, cerebellum and cerebellum.
At present, there are some functional near-infrared spectroscopy studies on the swallowing function of healthy people, which mainly focus on healthy young subjects, and studies show that the incidence of swallowing disorders increases with age, the incidence of swallowing disorders in people over 50 years old is 5.5% ~ 8%, and swallowing disorders are mainly concentrated in middle-aged and elderly people. At present, there are no studies on swallowing function in middle-aged and elderly healthy subjects with functional near-infrared spectroscopy. The purpose of this study is to explore and compare the cortical activation patterns and lateralization in the swallowing task of healthy middle-aged and elderly people and young people by using functional near-infrared spectroscopy, providing a theoretical basis for the exploration of swallowing function and further providing new ideas for the treatment of patients with swallowing disorders.
- Conditions
- Swallowing Disorder, Dysphagia, Swallowing Substances
- 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 |
|---|---|---|
| middle and old group | A total of 15 middle-aged and elderly subjects were selected. Resting state detection: After entering the NIR assessment room, the subjects sat comfortably for 5 minutes, and then wore fNIRS headcaps. The subjects were asked to sit quietly and avoid moving and thinking for 30 seconds. Task state detection: Subjects entered the NIR assessment room, sat comfortably for 5 minutes, and then wore fNIRS headcaps. After resting for 30 seconds, the subjects were asked to swallow, swallow saliva for 20 seconds, rest for 20 seconds, and repeat three times. | |
| young group | A total of 15 young subjects were selected. Resting state detection: After entering the NIR assessment room, the subjects sat comfortably for 5 minutes, and then wore fNIRS headcaps. The subjects were asked to sit quietly and avoid moving and thinking for 30 seconds. Task state detection: Subjects entered the NIR assessment room, sat comfortably for 5 minutes, and then wore fNIRS headcaps. After resting for 30 seconds, the subjects were asked to swallow, swallow saliva for 20 seconds, rest for 20 seconds, and repeat three times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional near-infrared spectroscopy
Resting state detection: After entering the NIR assessment room, the subjects sat comfortably for 5 minutes, and then wore fNIRS headcaps. The subjects were asked to sit quietly and avoid moving and thinking for 30 seconds.
Task state detection: Subjects entered the NIR assessment room, sat comfortably for 5 minutes, and then wore fNIRS headcaps. After resting for 30 seconds, the subjects were asked to swallow, swallow saliva for 20 seconds, rest for 20 seconds, and repeat three times.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start10 May 2024 (estimated)
- Primary completion10 Nov 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruyao Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruyao Liu, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xi Zeng, Study chair, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411236
- Sponsor's protocol ID
- 2020-PT310-04
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Response Characteristics of Brain Under Swallowing Task Paradigm Based on Functional Near-infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT06411236
- Acronym / sponsor ID
- 2020-PT310-04
- Conditions
- Swallowing Disorder, Dysphagia, Swallowing Substances
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruyao LiuUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 13 May 2024 (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.
Functional near-infrared spectroscopy was used to investigate the cortical activation patterns and lateralization during swallowing tasks in 15 healthy middle-aged and elderly people and 15 healthy young people. It provides a theoretical basis for the study of swallowing function and a new idea for the treatment of patients with swallowing disorders.
Detailed description
Swallowing is coordinated by hyoid muscle group, pharyngeal muscle and upper esophageal muscle, as well as the regulation of swallowing related functional brain area. Dysphagia refers to the inability to safely and effectively transport food from the mouth to the stomach to obtain adequate nutrition and water, resulting in eating difficulties. Studies have shown that swallowing disorders are mainly caused by stroke, brain trauma, neurodegenerative diseases (Alzheimer's disease, Parkinson's disease, multiple sclerosis and amyotrophic lateral sclerosis) and head and neck cancers (oral tumors, nasopharyngeal and laryngeal cancers). Moreover, the prevalence of dysphagia increases with age. Patients with dysphagia often have many complications, which may lead to dehydration, malnutrition, aspiration, pneumonia, etc., which greatly delays the recovery process of patients and reduces the quality of life of patients. Studies have shown that the swallowing network includes multiple brain regions, including the primary somatosensory cortex, primary motor cortex, bilateral premotor and auxiliary motor cortex, cingulate cortex, prefrontal, temporal, precuneus, subparietal lobule, cerebellum and cerebellum.
At present, there are some functional near-infrared spectroscopy studies on the swallowing function of healthy people, which mainly focus on healthy young subjects, and studies show that the incidence of swallowing disorders increases with age, the incidence of swallowing disorders in people over 50 years old is 5.5% ~ 8%, and swallowing disorders are mainly concentrated in middle-aged and elderly people. At present, there are no studies on swallowing function in middle-aged and elderly healthy subjects with functional near-infrared spectroscopy. The purpose of this study is to explore and compare the cortical activation patterns and lateralization in the swallowing task of healthy middle-aged and elderly people and young people by using functional near-infrared spectroscopy, providing a theoretical basis for the exploration of swallowing function and further providing new ideas for the treatment of patients with swallowing disorders.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| middle and old group | – | –A total of 15 middle-aged and elderly subjects were selected. Resting state detection: After entering the NIR assessment room, the subjects sat comfortably for 5 minutes, and then wore fNIRS headcaps. The subjects were asked to sit quietly and avoid moving and thinking for 30 seconds. Task state detection: Subjects entered the NIR assessment room, sat comfortably for 5 minutes, and then wore fNIRS headcaps. After resting for 30 seconds, the subjects were asked to swallow, swallow saliva for 20 seconds, rest for 20 seconds, and repeat three times. |
| young group | – | –A total of 15 young subjects were selected. Resting state detection: After entering the NIR assessment room, the subjects sat comfortably for 5 minutes, and then wore fNIRS headcaps. The subjects were asked to sit quietly and avoid moving and thinking for 30 seconds. Task state detection: Subjects entered the NIR assessment room, sat comfortably for 5 minutes, and then wore fNIRS headcaps. After resting for 30 seconds, the subjects were asked to swallow, swallow saliva for 20 seconds, rest for 20 seconds, and repeat three times. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People aged 18-25 who met the inclusion exclusion criteria were included in the younger group. People aged 50-70 who met the exclusion criteria were included in the Middle aged group.Subjects need to understand the swallowing task and cooperate well.
Key inclusion criteria (2 listed)
- Middle and old age group: 50~70 years old; Young group: 18~25 years old; Right-handed; No history of neurological, psychiatric, respiratory, or swallowing dysfunction; No brain injury, epilepsy, head and neck disease, gastroesophageal reflux disease; No cases of skull defect, head infection and skin damage that could not be detected by function near-infrared spectroscopy; Subjects signed informed consent forms in accordance with the Declaration of Helsinki.
- -
Key exclusion criteria (2 listed)
- pregnancy; poor patient compliance and non-cooperation with evaluation.
- -
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
Functional near-infrared spectroscopy
Time frame: day 1
Resting state detection: After entering the NIR assessment room, the subjects sat comfortably for 5 minutes, and then wore fNIRS headcaps. The subjects were asked to sit quietly and avoid moving and thinking for 30 seconds. Task state detection: Subjects entered the NIR assessment room, sat comfortably for 5 minutes, and then wore fNIRS headcaps. After resting for 30 seconds, the subjects were asked to swallow, swallow saliva for 20 seconds, rest for 20 seconds, and repeat three times.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.
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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.
Xi Zeng study chair
The First Affiliated Hospital of Zhengzhou University
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 Swallowing Disorder and Dysphagia, run by Ruyao Liu at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 13 May 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruyao Liu (+8615617749628, rio1274287008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional near-infrared spectroscopy (time frame: day 1). 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 13 May 2024.