Cognitive ImpairmentMoCANCT05187910
Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population
A study testing Speech Therapy, Swallowing Therapy and Upper Airway Therapy in people with Cognitive Impairment and Voice Disorders, run by University of California, San Francisco at 4 sites in United States.
Trial summary
This study will investigate if the performance on the Montreal Cognitive Assessment (MoCA) is associated or predictive of the outcomes in voice, swallowing or upper airway therapy in the older laryngology treatment seeking patients. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Cognitive Impairment, Voice Disorders, Voicebox Disorders
- What is being tested?
- Speech Therapy, Swallowing Therapy and Upper Airway Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2021to 1 Jul 2023
- Phase
- Interventional
- 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 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years or older with voice/swallowing/upper airway complaints
- Multidisciplinary assessment by fellowship-trained laryngologist and voice/swallow/upper airway specialized speech-language pathologist
- Voice, Swallowing and/or Upper airway disorder diagnosis
- Candidate for voice, swallowing or upper airway therapy following interdisciplinary assessment.
- State willingness to participate in the study protocol
Who cannot join
- Under the age of 60 years old
- Previously diagnosed dementia
- Central neurological disorder
- Active psychotic disorder
- Recurrent or active major depressive disorder (PHQ-9 of 10 or greater)
- Patient not able to attempt the MoCA because of a severe hearing or visual impairment
- Patients who do not speak or understand English
- Tested with MoCA in the last month
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Voice Center
Atlanta, Georgia, 30308
NYU Voice Center
New York, New York, 10017
Cornell Medical Center
New York, New York, 10065
UCSF Voice and Swallowing Center
San Francisco, California, 94115
About this study
This study will investigate if the performance on the Montreal Cognitive Assessment (MoCA) is associated or predictive of the outcomes in voice, swallowing or upper airway therapy in the older laryngology treatment seeking patients. The relationship between the scores of MoCA and parameters in therapy will be analyzed. The outcomes of this study could potentially impact how investigators determine candidacy for therapy and develop patient treatment plans to meet their needs. This is a collaborative study with Emory Voice Center and the NYU Voice Center.
- Conditions
- Cognitive Impairment, Voice Disorders, Voicebox Disorders, Cognitive Decline, Swallowing Disorder
- Being tested
- Speech Therapy, Swallowing Therapy, Upper Airway Therapy
- Keywords
- voice therapy, cough therapy, swallowing therapy
- Medical subject headings
- Cognitive Dysfunction, Voice Disorders, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech TherapyBehavioural
Training with a Speech Language Pathologists for voice disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps.
Swallowing TherapyBehavioural
Training with a Speech Language Pathologists for swallowing disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps.
Upper Airway TherapyBehavioural
Training with a Speech Language Pathologists for upper airway disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Voice Disorders | Active comparator | This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs). Receives: Behavioral: Speech Therapy |
| Patients with Swallowing Disorders | Active comparator | This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs). Receives: Behavioral: Swallowing Therapy |
| Patients with Upper Airway Disorders | Active comparator | This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs). Receives: Behavioral: Upper Airway Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Voice Handicap Index-10 Score Following Therapy
The Vocal Handicap Index-10 (VHI-10) will be used to obtain a quick, reliable, and quantifiable measure of patients' own vocal handicap perception. In 2004, Rosen et al designed a new shortened version of the first and broadly used global handicap assessment tool for voice disorders, the VHI. This questionnaire comprises 10 questions from the original 30 questions of the VHI and was called the VHI-10. The VHI-10 is a powerful representation of the VHI (30 items) to quantify patients' perception of their voice handicap. The VHI-10 has also been shown to be reliable, valid, and sensitive in a wide range of voice disorders (Rosen et al., 2004). This has a minimum value of 0 and a maximum value of 40. A higher score means a worse outcome.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Eating Assessment Tool-10 Score Following Therapy
The EAT-10 is a 10-question self-assessment tool to identify adults who exhibit signs and symptoms that may be indicative of dysphagia and who may require further referral. The EAT-10 has begun to be used in research with older adults in different settings, including an aged care facility (Wakabayashi \& Matsushima, 2016), acute hospital care (Matsuo, Yoshimura, Ishizaki, \& Ueno, 2016), and the community (Momoki et al., 2017). In the aged care setting, EAT-10 results suggesting the presence of dysphagia have been shown to be independently associated with a risk of malnutrition and impaired functional status (Wakabayashi \& Matsushima, 2016). This has a minimum value of 0 and a maximum value of 40. A higher score means a worse outcome.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Cough Severity Index Score Following Therapy
Cough Severity Index (CSI) is a short and self-administered questionnaire for patients with self-perceived symptoms of cough in order to quantify severity of chronic cough relating to upper airway disease and facilitate treatment outcomes. CSI helps quantify severity of cough in patients with chronic cough (CC) related to the upper airway. This has a minimum value of 0 and a maximum value of 40. A higher score means a worse outcome.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Dyspnea Index Score Following Therapy
Dyspnea Index (DI) is intended to serve as a quick and efficient patient-completed questionnaire to measure upper-airway related symptoms. The DI, by traditional psychometric standards, has good psychometric properties for patients with symptoms of upper airway dyspnea. This has a minimum value of 0 and a maximum value of 40. A higher score means a worse outcome.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Secondary outcomes (6)
Change in Voice Fundamental Frequency as Measured in the VoiceEvalu8 App Following Therapy
Candidates of voice and/or upper-airway therapy will be assessed by acoustic instruments that record and analyze the speaker's voice. Standard clinical measures will be taken.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Voice Cepstral Peak Prominence (CPP) as Measured in the VoiceEvalu8 App Following Therapy
Candidates of voice and/or upper-airway therapy will be assessed by acoustic instruments that record and analyze the speaker's voice. Standard clinical measures will be taken.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Acoustic Voice Quality Index (AVQI) as Measured in the VoiceEvalu8 App Following Therapy
Candidates of voice and/or upper-airway therapy will be assessed by acoustic instruments that record and analyze the speaker's voice. Standard clinical measures will be taken.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Iowa Oral Performance Instrument (IOPI) Following Therapy
Candidates of swallowing therapy (patients with dysphagia) will undergo standard instrumental swallowing assessment to assess tongue strength.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in DIGEST Scale Score Following Therapy
Candidates of swallowing therapy (patients with dysphagia) will undergo standard instrumental swallowing assessment to assess tongue strength and swallowing safety. The minimum score is a 0 and the maximum score is a 4. A higher score is a worse outcome and poorer swallowing safety.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Functional Oral Intake Scale (FOIS) Score Following Therapy
Candidates of swallowing therapy (patients with dysphagia) will undergo standard instrumental swallowing assessment to assess tongue strength and swallow function. The minimum score is a 1 and the maximum score is a 7. A 7 means a better outcome/diet without restrictions. A 1 would mean no intake orally.
Measured: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Mar 2021
- Primary completion1 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, New York University
- Responsible party
- Sponsor
- Investigators
- Clark Rosen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187910
- Sponsor's protocol ID
- 20-29913
- Acronym
- MoCA
- Status last verified
- Sep 2023
- First submitted
- 4 Nov 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leclerc AA, Gillespie AI, Tadic SD, Smith LJ, Rosen CA. The prevalence of cognitive impairment in laryngology treatment-seeking patients. Laryngoscope. 2020 Aug;130(8):2003-2007. doi: 10.1002/lary.28355. Epub 2019 Oct 25.
PubMed 31654439Shembel AC, Rosen CA, Zullo TG, Gartner-Schmidt JL. Development and validation of the cough severity index: a severity index for chronic cough related to the upper airway. Laryngoscope. 2013 Aug;123(8):1931-6. doi: 10.1002/lary.23916. Epub 2013 Jun 4.
PubMed 23737389Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.
PubMed 25311596Gartner-Schmidt J, Rosen C. Treatment success for age-related vocal fold atrophy. Laryngoscope. 2011 Mar;121(3):585-9. doi: 10.1002/lary.21122. Epub 2010 Aug 3.
PubMed 21344441Misono S, Yueh B, Stockness AN, House ME, Marmor S. Minimal Important Difference in Voice Handicap Index-10. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1098-1103. doi: 10.1001/jamaoto.2017.1621.
PubMed 28973078
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population
- ClinicalTrials.gov ID
- NCT05187910
- Acronym / sponsor ID
- MoCA / 20-29913
- Conditions
- Cognitive Impairment, Voice Disorders, Voicebox Disorders, Cognitive Decline, Swallowing Disorder
- Keywords
- voice therapy, cough therapy, swallowing therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Emory University, New York University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 12 Jan 2022 (actual)
- 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 if the performance on the Montreal Cognitive Assessment (MoCA) is associated or predictive of the outcomes in voice, swallowing or upper airway therapy in the older laryngology treatment seeking patients. The relationship between the scores of MoCA and parameters in therapy will be analyzed. The outcomes of this study could potentially impact how investigators determine candidacy for therapy and develop patient treatment plans to meet their needs. This is a collaborative study with Emory Voice Center and the NYU Voice Center.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Voice Disorders | Active comparator | Behavioral: Speech TherapyThis is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs). |
| Patients with Swallowing Disorders | Active comparator | Behavioral: Swallowing TherapyThis is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs). |
| Patients with Upper Airway Disorders | Active comparator | Behavioral: Upper Airway TherapyThis is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs). |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 years or older with voice/swallowing/upper airway complaints
- Multidisciplinary assessment by fellowship-trained laryngologist and voice/swallow/upper airway specialized speech-language pathologist
- Voice, Swallowing and/or Upper airway disorder diagnosis
- Candidate for voice, swallowing or upper airway therapy following interdisciplinary assessment.
- State willingness to participate in the study protocol
Key exclusion criteria (8 listed)
- Under the age of 60 years old
- Previously diagnosed dementia
- Central neurological disorder
- Active psychotic disorder
- Recurrent or active major depressive disorder (PHQ-9 of 10 or greater)
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 |
|---|---|---|
| Speech TherapyTraining with a Speech Language Pathologists for voice disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps. | Behavioural | Patients with Voice Disorders |
| Swallowing TherapyTraining with a Speech Language Pathologists for swallowing disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps. | Behavioural | Patients with Swallowing Disorders |
| Upper Airway TherapyTraining with a Speech Language Pathologists for upper airway disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps. | Behavioural | Patients with Upper Airway Disorders |
Primary outcome
Change in Voice Handicap Index-10 Score Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
The Vocal Handicap Index-10 (VHI-10) will be used to obtain a quick, reliable, and quantifiable measure of patients' own vocal handicap perception. In 2004, Rosen et al designed a new shortened version of the first and broadly used global handicap assessment tool for voice disorders, the VHI. This questionnaire comprises 10 questions from the original 30 questions of the VHI and was called the VHI-10. The VHI-10 is a powerful representation of the VHI (30 items) to quantify patients' perception of their voice handicap. The VHI-10 has also been shown to be reliable, valid, and sensitive in a wide range of voice disorders (Rosen et al., 2004). This has a minimum value of 0 and a maximum value of 40. A higher score means a worse outcome.
Change in Eating Assessment Tool-10 Score Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
The EAT-10 is a 10-question self-assessment tool to identify adults who exhibit signs and symptoms that may be indicative of dysphagia and who may require further referral. The EAT-10 has begun to be used in research with older adults in different settings, including an aged care facility (Wakabayashi \& Matsushima, 2016), acute hospital care (Matsuo, Yoshimura, Ishizaki, \& Ueno, 2016), and the community (Momoki et al., 2017). In the aged care setting, EAT-10 results suggesting the presence of dysphagia have been shown to be independently associated with a risk of malnutrition and impaired functional status (Wakabayashi \& Matsushima, 2016). This has a minimum value of 0 and a maximum value of 40. A higher score means a worse outcome.
Change in Cough Severity Index Score Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Cough Severity Index (CSI) is a short and self-administered questionnaire for patients with self-perceived symptoms of cough in order to quantify severity of chronic cough relating to upper airway disease and facilitate treatment outcomes. CSI helps quantify severity of cough in patients with chronic cough (CC) related to the upper airway. This has a minimum value of 0 and a maximum value of 40. A higher score means a worse outcome.
Change in Dyspnea Index Score Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Dyspnea Index (DI) is intended to serve as a quick and efficient patient-completed questionnaire to measure upper-airway related symptoms. The DI, by traditional psychometric standards, has good psychometric properties for patients with symptoms of upper airway dyspnea. This has a minimum value of 0 and a maximum value of 40. A higher score means a worse outcome.
6 secondary outcomes
Change in Voice Fundamental Frequency as Measured in the VoiceEvalu8 App Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Voice Cepstral Peak Prominence (CPP) as Measured in the VoiceEvalu8 App Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Acoustic Voice Quality Index (AVQI) as Measured in the VoiceEvalu8 App Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Iowa Oral Performance Instrument (IOPI) Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in DIGEST Scale Score Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
Change in Functional Oral Intake Scale (FOIS) Score Following Therapy
Time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.
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 26 Sep 2023.
- Background: PubMed 31654439Leclerc AA, Gillespie AI, Tadic SD, Smith LJ, Rosen CA. The prevalence of cognitive impairment in laryngology treatment-seeking patients. Laryngoscope. 2020 Aug;130(8):2003-2007. doi: 10.1002/lary.28355. Epub 2019 Oct 25.
- Background: PubMed 23737389Shembel AC, Rosen CA, Zullo TG, Gartner-Schmidt JL. Development and validation of the cough severity index: a severity index for chronic cough related to the upper airway. Laryngoscope. 2013 Aug;123(8):1931-6. doi: 10.1002/lary.23916. Epub 2013 Jun 4.
- Background: PubMed 25311596Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.
- Background: PubMed 21344441Gartner-Schmidt J, Rosen C. Treatment success for age-related vocal fold atrophy. Laryngoscope. 2011 Mar;121(3):585-9. doi: 10.1002/lary.21122. Epub 2010 Aug 3.
- Background: PubMed 28973078Misono S, Yueh B, Stockness AN, House ME, Marmor S. Minimal Important Difference in Voice Handicap Index-10. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1098-1103. doi: 10.1001/jamaoto.2017.1621.
- Individual participant dataSharing planned: No
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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.
Clark Rosen, MD principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Therapy, Swallowing Therapy and Upper Airway Therapy in people with Cognitive Impairment and Voice Disorders, run by University of California, San Francisco at 4 sites 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 5 inclusion and 8 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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.
What does the primary outcome measure?
Change in Voice Handicap Index-10 Score Following Therapy (time frame: Recorded at initial clinic visit and follow-up visit after completion of speech therapy. Typically a time scale of 6-12 weeks depending on how soon speech/swallow/upper airway therapy is started.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05187910, which also lists 5 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 26 Sep 2023.