Clinical trial NCT05187910: Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population
Official title: Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Voice Disorders
Voicebox Disorders
Cognitive Decline
Swallowing Disorder
Keywords: voice therapy
cough therapy
swallowing therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Emory University
name: New York University
First posted: 2022-01-12
Enrollment: 57
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Change in Voice Handicap Index-10 Score Following Therapy
timeFrame: 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.
measure: Change in Eating Assessment Tool-10 Score Following Therapy
timeFrame: 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.
measure: Change in Cough Severity Index Score Following Therapy
timeFrame: 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.
measure: Change in Dyspnea Index Score Following Therapy
timeFrame: 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:
measure: Change in Voice Fundamental Frequency as Measured in the VoiceEvalu8 App Following Therapy
timeFrame: 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.
measure: Change in Voice Cepstral Peak Prominence (CPP) as Measured in the VoiceEvalu8 App Following Therapy
timeFrame: 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.
measure: Change in Acoustic Voice Quality Index (AVQI) as Measured in the VoiceEvalu8 App Following Therapy
timeFrame: 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.
measure: Change in Iowa Oral Performance Instrument (IOPI) Following Therapy
timeFrame: 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.
measure: Change in DIGEST Scale Score Following Therapy
timeFrame: 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.
measure: Change in Functional Oral Intake Scale (FOIS) Score Following Therapy
timeFrame: 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.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Voice and Swallowing Center
state: California
city: Atlanta
country: United States
facility: Emory Voice Center
state: Georgia
city: New York
country: United States
facility: NYU Voice Center
state: New York
city: New York
country: United States
facility: Cornell Medical Center
state: New York
Study officials:
affiliation: University of California, San Francisco
name: Clark Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.