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Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population (MoCA)

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ClinicalTrials.gov Identifier: NCT05187910
Recruitment Status : Enrolling by invitation
First Posted : January 12, 2022
Last Update Posted : January 12, 2022
Sponsor:
Collaborators:
Emory University
New York University
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Voice Disorders Voicebox Disorders Cognitive Decline Swallowing Disorder Behavioral: Speech Therapy Behavioral: Swallowing Therapy Behavioral: Upper Airway Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patients with Voice Disorders
This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs).
Behavioral: Speech Therapy
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.

Active Comparator: Patients with Swallowing Disorders
This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs).
Behavioral: Swallowing Therapy
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.

Active Comparator: Patients with Upper Airway Disorders
This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs).
Behavioral: Upper Airway Therapy
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.

  3. 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. ]
    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.

  4. 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. ]
    Candidates of swallowing therapy (patients with dysphagia) will undergo standard instrumental swallowing assessment to assess tongue strength.

  5. 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. ]
    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.

  6. 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05187910


Locations
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United States, California
UCSF Voice and Swallowing Center
San Francisco, California, United States, 94115
United States, Georgia
Emory Voice Center
Atlanta, Georgia, United States, 30308
United States, New York
NYU Voice Center
New York, New York, United States, 10017
Sponsors and Collaborators
University of California, San Francisco
Emory University
New York University
Investigators
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Principal Investigator: Clark Rosen, MD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05187910    
Other Study ID Numbers: 20-29913
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
voice therapy
cough therapy
swallowing therapy
Additional relevant MeSH terms:
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Deglutition Disorders
Voice Disorders
Disease
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases