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

NCT05187910 | Completed DMC

• 1 other identifier: 20-29913
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 4

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.

Conditions

Cognitive Impairment; Voice Disorders; Voicebox Disorders; Cognitive Decline; Swallowing Disorder

Keywords

voice therapy; cough therapy; swallowing therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (3)

Patients with Voice Disorders

ACTIVE COMPARATOR

This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs).

Behavioral: Speech Therapy

Patients with Swallowing Disorders

ACTIVE COMPARATOR

This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs).

Behavioral: Swallowing Therapy

Patients with Upper Airway Disorders

ACTIVE COMPARATOR

This is typically diagnosed by MDs in conjunction with Speech Language Pathologists (SLPs).

Behavioral: Upper Airway Therapy

Interventions

Speech Therapy BEHAVIORAL

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.

Patients with Voice Disorders

Swallowing Therapy BEHAVIORAL

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.

Patients with Swallowing Disorders

Upper Airway Therapy BEHAVIORAL

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.

Patients with Upper Airway Disorders

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Emory University: collaborator
• New York University: collaborator

Study Sites (4)

UCSF Voice and Swallowing Center

San Francisco, California, 94115, United States

Location

Emory Voice Center

Atlanta, Georgia, 30308, United States

Location

NYU Voice Center

New York, New York, 10017, United States

Location

Cornell Medical Center

New York, New York, 10065, United States

Location

Related Publications (5)

• 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.

  PMID: 31654439 BACKGROUND

• Shembel 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.

  PMID: 23737389 BACKGROUND

• Gartner-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.

  PMID: 25311596 BACKGROUND

• Gartner-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.

  PMID: 21344441 BACKGROUND

• Misono 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.

  PMID: 28973078 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Voice Disorders; Deglutition Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Clark Rosen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: January 12, 2022
• Study Start: March 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)