Spastic DysphoniaPhase 1NCT00015795
Study of Air Stream in Voice Production
A Phase 1 study testing airway interruption test in people with Spastic Dysphonia and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spastic Dysphonia, Healthy
- What is being tested?
- airway interruption test
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Jun 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Criteria for inclusion of patients with ABSD:
- 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.
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- 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.
- Criteria for inclusion for normal volunteers:
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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
- phonation threshold pressures should be greater than normal in persons with ABSD, and
- 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.
- Conditions
- Spastic Dysphonia, Healthy
- Being tested
- airway interruption test
- Keywords
- Pressure, Botulinum Toxin, Voice, Dystonia, Pathophysiology, Healthy Volunteer, HV, ABSD, Spasmodic Dysphonia, Abductor Spasmodic Dysphonia
- Medical subject headings
- Dysphonia, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway interruption testDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2001 (estimated)
- Study startMay 2001
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spastic DysphoniaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015795
- Sponsor's protocol ID
- 010169
- Other IDs
- 01-N-0169
- Status last verified
- Jun 2003
- First submitted
- 4 May 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 1738288Bocchino 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.
PubMed 209266Finnegan 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.
PubMed 8820702
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Resistance in Abductor Spasmodic Dysphonia
- ClinicalTrials.gov ID
- NCT00015795
- Acronym / sponsor ID
- 010169
- Conditions
- Spastic Dysphonia, Healthy
- Keywords
- Pressure, Botulinum Toxin, Voice, Dystonia, Pathophysiology, Healthy Volunteer, HV, ABSD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- May 2001
- Study completion
- Jun 2003
- First posted
- 7 May 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- phonation threshold pressures should be greater than normal in persons with ABSD, and
- 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| airway interruption test | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 1738288Blitzer 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.
- Background: PubMed 209266Bocchino 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.
- Background: PubMed 8820702Finnegan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing airway interruption test in people with Spastic Dysphonia and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00015795, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.