Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0515163804
Study information
Scientific title
Fibreoptic endoscopic evaluation of swallowing (FEES): Therapy or Assessment
Acronym
Study hypothesis
The hypothesis is that visual & verbal feedback improves the ability of participants to correctly perform specific movements within the pharynx to command. In addition to this I am hypothesising that FEES is a valuable therapeutic tool with regards to comfort, acceptability, time and resources. To date there is no documented evidence supporting the use of Nasendoscopy as a therapeutic tool, despite the obvious clinical benefits.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Diagnostic
Patient information sheet
Condition
Digestive System: Deglutition disorders
Intervention
Group 1 Participants of the study will be assigned to one of two groups. All participants will be given information about the anatomy of the pharynx and larynx. This will be done using diagrams. With the aid of the diagram, the participant will then be given information about the precise target movements expected of them. These include: Nasopharyngeal closure, tongue base reaction, vocal fold adduction and the posterior pharyngeal wall. The scope will then be passes transnasally to enable three views the nasopharyngeal port, the pharynx and the larynx.
Participants randomised to group 2 will be positioned to allow viewing of their anatomy. The whole assessment process will be videotaped to allow for inter-rate reliability to be established. The participant will be instructed to attempt to each movement in turn and they will be given 3 minutes to perfect this movement. The participant will then be instructed to attempt to perform the movement 5 times consecutively. The movement will be scored as present or absent and a score out of 5 will be given. Group 2 participants will be scoped as before to allow the therapist full view of the movements achieved in the pharynx and this that are not. The participant will not however be able to view the monitor. The participants in this group will receive the same amount of feedback that would normally be available for patients receiving therapy with out the help of nasendoscopy. The investigator will provide them with information about the target movements. Group 2 participants will be given a practice period of 3 minutes per movement. The participant will then be asked to perform the target movements 5 times and the researcher will record the consistency with which they are achieved.
As with group 1, all the assessment results will be recorded on to videotape. The assessment time in total should not exceed 20 minutes. Analysis of the results will be achieved using a chi squared statistical test.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Measurement of the target movement. Assessment as to whether or not these movements have been achieved will be rate by the principal investigator and the data will be re-rated by a further therapist skilled in this area
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2002
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Participants will be selected and randomly assigned into two groups. Each group will consist of 10 healthy volunteers with no history of swallowing difficulties. Participants will be recruited predominantly from staff working at Northwick Park Hospital.
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Patients under 18
2. Patients with swallowing difficulties
Recruitment start date
01/07/2002
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northwick Park Hospital
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North West London Hospitals NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary