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

NCT ID: NCT05187910

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Impairment Voice Disorders Voicebox Disorders Cognitive Decline Swallowing Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with Voice Disorders

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

Group Type ACTIVE_COMPARATOR

Speech Therapy

Intervention Type 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 Swallowing Disorders

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

Group Type ACTIVE_COMPARATOR

Swallowing Therapy

Intervention Type 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 Upper Airway Disorders

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

Group Type ACTIVE_COMPARATOR

Upper Airway Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

New York University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clark Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF Voice and Swallowing Center

San Francisco, California, United States

Site Status

Emory Voice Center

Atlanta, Georgia, United States

Site Status

NYU Voice Center

New York, New York, United States

Site Status

Cornell Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31654439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23737389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25311596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21344441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28973078 (View on PubMed)

Other Identifiers

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20-29913

Identifier Type: -

Identifier Source: org_study_id

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