Validation of a device for monitoring laryngeal motion during swallowing

JRCT ID: jRCTs042240145

Registered date:13/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dysphasia
• Date of first enrollment: 13/12/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Subject will be conducted to swallow attached laryngeal motion monitor on them flont neck.
Measurement items are 4 saliva swallow and 4 liquid swallow (In case of subject with modelate or severe dysphasia, thickend liquid will be use). Each swallowing dynamics will be detected underwent X-ray.

Outcome(s)

Primary Outcome

Laryngeal motion captured during swallowing by a swallowing motion monitor
Laryngeal motion during swallowing detected by X-ray fluoroscopy

Secondary Outcome

Laryngeal elevation duration during swallowing captured by a swallowing motion monitor
Laryngeal elevation duration during swallowing detected by X-ray fluoroscory

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. healthy subjects over 20 years old who have no history of stroke, neuromuscular or cardiac diseases and have given informed consent for this study
2. patients with dysphagia aged 20 years or older who are inpatients or outpatients of the Rehabilitation Department of our hospital, are in stable general condition, and have given informed consent for this study.

Exclude criteria

1. patients with complaints of dysphagia, stroke, neuromuscular diseases, organic diseases of the larynx and pharynx, respiratory diseases, or upper digestive diseases
2. patients with unstable general condition, patients who are unable to perform voluntary movements due to impaired consciousness, patients who cannot receive instructions from a therapist, and patients whom the principal investigator or subinvestigators deem inappropriate

Related Information

• Primary Sponsor: Otaka Yohei
• Secondary Sponsor: BANDO Chemical Industries