All the patients will be reviewed for inclusion and exclusion of the study in detailed
manner using medical evaluation form. The physical examination part of the medical
evaluation form will be filled out by one of our designated physician investigators. A
urine pregnancy test will be administered if necessary at this time.
The patient's neck physical dimensions and device's physical dimensions will be measured
and recorded using the Biometric form.
A baseline functional outcome assessment of swallowing (FOAMS) will be performed for each
patient.
Patients will be sitting in an upright position with the head held in neutral position at
Fluoroscopy lab and acclimatized for 10 minutes before proceeding.
Patient's anatomic structure and landmarks are identified in both lateral and
anteroposterior (AP) views with fluoroscopy.
A 4 mm diameter catheter with 3 markers 3 cm apart will be placed on the skin in the
pharyngo-UES region for the purpose of calibration and nullify the error from
magnification during videorecording.
Patient will be asked to swallow barium suspension at incremental volumes of 1, 3 and 5
ml; however, if the patient develops aspiration or doesn't tolerate barium suspension
higher volumes will not be administered. Following are test swallows under fluoroscopy:
1 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 3 ml- 40%
weight/volume barium suspension at room temperature x 3 times each. 5 ml- 40%
weight/volume barium suspension at room temperature x 3 times each. The fluoroscopy
machine will be turned "on" for 5 seconds ONLY during each swallow. Rest of the time
fluoroscopy machine will be turned "off".
Fluoroscopic recordings were obtained at 90 kilo-electron-volt (KeV), using a 9-inch
image-intensifier mode and appropriate collimation so that an image was obtained of the
posterior mouth, pharynx, and pharyngoesophageal region. Fluoroscopic recordings will be
timed using a specially designed timer.
After the baseline fluoroscopic study, each patient will be randomized to receive either
the sham exerciser (i.e. device with no pressure) or pharyngeal exerciser (i.e. device
with graded pressure).
Study Groups:
Pharyngeal exerciser group: In this group, the device will be placed around the neck
overlying the laryngeal cartilage. The device will be in contact with the skin without
any underlying pressure using the Velcro fastening in the back of neck. The externally
applied pressure will be measured by means of the pressure gauge included in the device
(see figure). Patients are asked to follow exercise regimen: to perform 30 swallows at 15
seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser
over larynx during the first 2 weeks. This is repeated 3 times per day and the external
resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40
mm Hg in another 2 weeks.
Sham exerciser group: In this group, sham device will be placed around the neck overlying
the laryngeal cartilage. No external pressure will be applied during exercise. These
patients will be asked to follow the exercise regimen: to perform repetitive tongue
protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6
weeks.
All the exercise instructions and log record will be given to each of the patient in both
study groups at the time of randomization. The exerciser (sham or pharyngeal) will be
worn only at the time of exercises.
Weekly telephone interviews will be conducted to assess their progress and address their
concerns in both study groups.
Patients in both study groups are required to make follow up visits every 2 weeks. During
the follow up visits, patients will be reviewed for symptom severity and resistance of
the device. This information is documented in patient progress sheet and follow up visit
form. All the adverse events during the study or from the device will be documented in
the adverse and serious adverse events form. The compliance with the device will be
evaluated by examining the exercise log sheet.
After 6 weeks, the device (sham exerciser or pharyngeal exerciser) will be returned to
the study team and patients will be asked to complete functional outcome assessment of
swallowing (FOAMS).
Each patient will undergo follow up fluoroscopic study with the same test swallows as the
baseline swallows, looking for pharyngeal residue and aspiration (repeat steps: 4 to 9).
All the fluoroscopic images will be recorded and stored in digitalized format at 30
frames (60 fields/second) in a secure location at the research lab (locked in safe
location and accessible only to the investigators). These the fluoroscopic studies will
be analyzed for the study parameters as mentioned below by two individuals in a blinded
fashion.
At the end of study period, each of the patients in sham group will be given an option to
undergo another 6 weeks of pharyngeal exercise using pharyngeal exerciser. If they
consent again(using informed consent form) to participate, they would be following above
exercise protocol(30 swallows against 20 mm Hg of resistance with pharyngeal exerciser
three times a day for 2 weeks; followed by swallowing exercise with incremental
resistance of 30 and 40 mm Hg for 2 weeks each). At of 6 weeks, they would undergo repeat
fluoroscopy study to check for improvement in pharyngeal residue (repeat steps: 4 to 9).
The participants will be followed after completion of the exercise regimen for a total of
12 months. At 3 months after the completion of initial exercise study, the participant
will be contacted and informed about the follow up portion of the study. If they are in
agreement, the participant will be asked to come to the lab to be reconsented and
complete an EAT-10 form. At this time, the participant will be asked questions such as
current diet consistency, evidence of cough with eating, additional time needed during
meals, etc to determine FOAMS score. The patient will only be interviewed after consent
is obtained. At 6 months, the subjects will undergo repeat fluoroscopy for an objective
measure of their swallowing. At this visit they will also be asked to complete an EAT-10
form and a FOAMS score will again be determined. At 12 months, the participant will not
be required to return to the lab. They will also be mailed a swallowing assessment form
(EAT-10) to be filled out and returned at 12 months (subjects will be asked to complete
the paper form for consistency). The participant will also be contacted for a telephone
interview to be asked questions such as current diet consistency, evidence of cough with
eating, additional time needed during meals, etc to determine FOAMS score. For those
subjects who are newly enrolled, re-consent will not occur since there is only one
consent form which includes the follow-up information. Newly enrolled subjects will be
presented with the follow-up information at the time of initial consent.
During the entire study period, the participant will be instructed to continue their
standard of medical care (medications, diet, physical therapy and activity) as suggested
by their personnel physician.
All the fluoroscopic studies will be analyzed by two individuals in a blinded fashion.
After the completion of the study, individuals in the sham exerciser group will be given
the option of doing exercises using pharyngeal exerciser. If they are interested, consent
will be obtained using new consent form before re-enrolling into the study.