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

Sponsor

University of California, San Francisco (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05187910

Collaborator

Emory University (Other), New York University (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Voice Handicap Index-10 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.]
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 [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 [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 [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

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.]
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.
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.]
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.
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.]
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.
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.]
Candidates of swallowing therapy (patients with dysphagia) will undergo standard instrumental swallowing assessment to assess tongue strength.
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.]
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.
Change in Functional Oral Intake Scale (FOIS) 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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Voice and Swallowing Center	San Francisco	California	United States	94115
2	Emory Voice Center	Atlanta	Georgia	United States	30308
3	NYU Voice Center	New York	New York	United States	10017