Healthy Clinical Trial
Official title:
Laryngeal Resistance in Abductor Spasmodic Dysphonia
This study will investigate and compare the air stream during voice production in patients
with abductor spasmodic dysphonia and in normal volunteers. People with abductor spasmodic
dysphonia have uncontrolled muscle spasms during speech, resulting in a weak voice. A better
understanding of the abnormalities of this disorder may help in the development of more
effective treatments.
Healthy volunteers and patients with abductor spasmodic dysphonia may be eligible for this
study. Candidates will have a physical examination and medical history. (Patients will be
videotaped and voice-recorded during the medical interview for review by specialists who
will identify the type and severity of their speech disorder.) All candidates will also
undergo a procedure called flexible fiberoptic laryngoscopy to record the movement of the
vocal folds during speech, breathing and other tasks such as singing, whistling and
prolonging vowels. For this test, the inside of the nose is sprayed with an anesthetic
(lidocaine) to numb the nasal cavity and a decongestant (oxymetazoline) to widen the nasal
passage. Then, a thin flexible tube called a nasolaryngoscope is passed through the nose to
the larynx (voice box). A camera attached to the eyepiece of the nasolaryngoscope records
the movements of the vocal folds.
Participants will then have an airway interruption test to detect pressure changes in the
voice box during production of continuous sounds. A nose clip is placed over the subject's
nose and two sensor devices are placed on the neck to pick up changes in movement and
position of the vocal cords during voicing. A mouthpiece is placed in the mouth, and
subjects are asked to say "ah" continuously at a specified sound level. This voicing is
repeated 33 times with periodic breaks.
Patients only will also be given an injection of botulinum toxin. These injections are
effective, in varying degrees, in about 60 percent of patients with abductor spasmodic
dysphonia. This study will use a different approach to botulinum toxin injections to test
their effect in patients with pressures higher than normal. Rather than inject the posterior
cricoarytenoid muscle or the cricothyroid muscle, as is typically done, the thyroarytenoid
muscle, which closes the voice box, will be injected on one side. A second one-sided
injection may be given after 2 or 3 weeks if no effect is seen after the first injection.
Speech will be recorded at each visit to measure any change in symptoms after the injection.
Persons with abductor spasmodic dysphonia (ABSD) have difficulties with phonation onset
after voiceless consonants resulting in breathy breaks. Previously, ABSD was thought to
involve heightened activity of the laryngeal abductor muscle, the posterior cricoarytenoid.
Botulinum toxin injection of the posterior cricoarytenoid muscle in this disorder, however,
only provides a partial benefit in about 50% of persons with ABSD. An electromyographic
study of the laryngeal muscles in ABSD found asymmetries in the adductor muscle (the
thyroarytenoid muscle) in ABSD. Thyroarytenoid (TA) activation levels differed between the
two sides in persons with ABSD. An electromyographic study of the laryngeal muscles in ABSD
found asymmetries in the adductor muscle (the thyroarytenoid muscle) in ABSD. Thyroarytenoid
(TA) activation levels differed between the two sides in persons with ABSD in comparison
with controls; the right TA showed greater activity than the left. This suggested that ABSD
might involve increased tone on one side of the larynx, and that treatment should address
any such asymmetry in muscle tone. We hypothesize that if TA muscle activity was greater on
one side in ABSD, then
A) phonation threshold pressures should be greater than normal in persons with ABSD, and
B) that treatment with botulinum toxin in those with phonation threshold pressures greater
than normal should show symptom reduction following injection of the TA muscles on one side.
Both normal volunteers and persons with ABSD will be studied. Phonation Threshold Pressure
(PTP) will be measured using the brief interruption of supraglottal airflow with a valve
during phonation into a tube. The electroglottographic signals will be used to determine
when vocal fold vibration ceases after the valve closes. The PTP will be measured as the
difference between an estimate of the subglottal pressure achieved after phonation offset
following valve closure, and the minimum subglottal vocal tract pressure at the point just
before vocal fold vibration ceases following the interruption of airflow. Persons with ABSD
who have higher phonation threshold pressures than normal will then receive an injection
with botulinum toxin injection into the thyroarytenoid muscle on one side based on movement
asymmetries observed on fiberoptic nasolaryngoscopy. Blinded measures of symptom frequency
made before and after treatment will determine if symptoms are improved.
;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |