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Completed Phase 1 Interventional Accepts healthy volunteers

Study of Air Stream in Voice Production

ClinicalTrials.gov ID: NCT00015795

Public ClinicalTrials.gov record NCT00015795. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Laryngeal Resistance in Abductor Spasmodic Dysphonia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00015795
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
30 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2001
Primary completion
Not listed
Completion
May 31, 2003
Last update posted
Mar 3, 2008

2001 – 2003

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00015795, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 3, 2008 · Synced Sep 5, 2026

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