Status:
RECRUITING
Modelling of Pharyngeal Laryngeal Effectiveness
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
National Research Agency, France
Institut de Recherche en Informatique de Toulouse (IRIT)
Conditions:
Swallowing Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to collect the signals of pharyngeal laryngeal activity through five non-invasive sensors (microphone, accelerometer, surface electromyography (EMG), nasal cannula and oxi...
Detailed Description
The process of swallowing is complex and difficult to assess because of its dynamic nature, the lack of specialists and the technical means necessary for its exploration. Thus, the majority of patient...
Eligibility Criteria
Inclusion
- Inclusion criteria for patients with swallowing disorders :
- Indication to perform a swallowing test (suspected or proven swallowing disorder or presence of a complication)
- Able to follow up by phone for 6 months or have a caregiver who can answer for them
- Affiliated subject or beneficiary of the social security system
- Consent to participate obtained in writing and signed by the subject or, if applicable, the next of kin/support person
- Inclusion criteria for healthy volunteers :
- No swallowing disorder or discomfort (DHI score\<8)
- Affiliated subject or beneficiary of the social security system
- Signed Consent to Participate
- Non-inclusion criteria for patients with swallowing disorders :
- Skin lesion(s) at the neck
- Tracheotomy or tracheostomy (laryngectomy)
- Nasogastric probe
- Iodine allergy
- Asthma
- Refusal or any pathology incompatible with passing one of the two reference exams or the sensors used
- Any serious pathology (severe health or behavioral disorders) where, according to the investigator, this could expose participants to additional risks
- Legal protection (guardianship, curators, safeguarding of justice)
- Pregnant and lactating women
- Non-inclusion criteria for healthy volunteers :
- Medical history may result in chronic (history of oral-rhino-laryngeal cancer or neurological disease) or temporary (upper respiratory tract infections) swallowing impairment
- Presence of swallowing disorder or discomfort (Deglutition Handicap Index score superior or equal to 8)
- Skin lesion(s) at the neck
- Tracheotomy or tracheostomy (laryngectomy)
- Nasogastric probe
- Iodine allergy
- Asthma
- Refusal or any pathology incompatible with passing one of the two reference exams or the sensors used
- Any serious pathology (severe health or behavioral disorders) where, according to the investigator, this could expose participants to additional risks
- Legal protection (guardianship, curators, safeguarding of justice)
- Pregnant and lactating women
Exclusion
Key Trial Info
Start Date :
April 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT06014710
Start Date
April 14 2023
End Date
December 1 2026
Last Update
June 13 2025
Active Locations (4)
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1
University hospital of Bordeaux
Bordeaux, France, 33000
2
University hospital of Rouen
Rouen, France, 76038
3
University Hospital of Toulouse
Toulouse, France, 31059
4
University hospital of Tours
Tours, France, 37000