NCT06411236

Brief 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. It provides a theoretical basis for the study of swallowing function and a new idea for the treatment of patients with swallowing disorders.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 8, 2024

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    day 1

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • pregnancy; poor patient compliance and non-cooperation with evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of zhengzhou university

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Xi Zeng

    The First Affiliated Hospital of Zhengzhou University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 13, 2024

Study Start

May 10, 2024

Primary Completion

November 10, 2024

Study Completion

December 10, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

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.

Locations