Study of Air Stream in Voice Production

NCT00015795 | Completed Phase 1

• 2 other identifiers: 01016901-N-0169
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spastic Dysphonia; Healthy

Keywords

Pressure; Botulinum Toxin; Voice; Dystonia; Pathophysiology; Healthy Volunteer; HV; ABSD; Spasmodic Dysphonia; Abductor Spasmodic Dysphonia

Interventions

airway interruption test DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General Criteria:
• Symptoms present during speech and not apparent at rest.
• Symptoms less evident during whisper, singing or falsetto.
• Symptoms which become worse with prolonged speaking, practice or anxiety.
• Reflexive and emotional aspects of voice function are unaffected, such as coughing, laughter or crying.
• No surgical treatment for ABSD or injections with botulinum toxin in the last 9 months.
• Willing to undergo a botulinum toxin injection in the thyroarytenoid muscle.
• Diagnostic Characteristics:
• Prolonged vocal fold opening during voiceless consonants with excessive breathiness, as individuals experience difficulties in closing the vocal folds to produce vowels following voiceless consonants (p, t, k, s, f, h, th). Sounds such as "s", "h", or "k" when coming just before open vowels such as "ah" and "uh" as in "home", "coffee", and puppy" are usually most affected.
• Normal vocal fold movement control for non-speech tasks such as cough, throat clearance and Valsalva maneuver during fiberoptic nasopharyngoscopy.
• Persons without pulmonary, neurological, otolaryngological, psychiatric or speech, voice and hearing problems as determined by medical history and examination by a physician.
• Persons without a respiratory difficulties such as asthma, bronchitis, or chronic obstructive pulmonary disease.
• No smokers or tobacco users.

You may not qualify if:

• The Following individuals will be excluded fro participation in the study:
• Any person with a history of respiratory difficulties such as asthma, bronchitis, or chronic obstructive pulmonary disease.
• Any person with abnormalities of the larynx such as benign laryngeal disease, laryngeal carcinoma, and laryngeal congenital anomaly.
• Any persons with reduction in vocal fold movement range during non-speech tasks, such as whistling, which would suggest either vocal fold paralysis or cricoarytenoid joint fixation or neoplasm.
• Any person with a functional voice disorder such as whispering aphonia or complete aphonia, or muscular tension dysphonia.
• Any person who report periods of symptom remission or are atypical of spasmodic dysphonia.
• Any person with oropharyngeal abnormalities such as velopharyngeal insufficiency, or neuromuscular disorders.
• Smokers and tobacco users.
• Any person who are currently under treatment for a major depression or manic-depressive illness, schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Blitzer A, Brin MF, Stewart C, Aviv JE, Fahn S. Abductor laryngeal dystonia: a series treated with botulinum toxin. Laryngoscope. 1992 Feb;102(2):163-7. doi: 10.1288/00005537-199202000-00011.

  PMID: 1738288 BACKGROUND

• Bocchino JV, Tucker HM. Recurrent laryngeal nerve pathology in spasmodic dysphonia. Laryngoscope. 1978 Aug;88(8 Pt 1):1274-8. doi: 10.1288/00005537-197808000-00008.

  PMID: 209266 BACKGROUND

• Finnegan EM, Luschei ES, Barkmeier JM, Hoffman HT. Sources of error in estimation of laryngeal airway resistance in persons with spasmodic dysphonia. J Speech Hear Res. 1996 Feb;39(1):105-13. doi: 10.1044/jshr.3901.105.

  PMID: 8820702 BACKGROUND

MeSH Terms

Conditions

Dysphonia; Dystonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 4, 2001
• First Posted: May 7, 2001
• Study Start: May 1, 2001
• Study Completion: June 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2003-06

Locations

US (1)