Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2013-12-31
2016-11-30
Brief Summary
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Detailed Description
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Assessment Protocol
Each participant will receive the Complete Evaluation Protocol at Baseline, after 3 weeks(PERIOD 1), after an additional 3 weeks (PERIOD 2), as well as at 3, 6, and 12 months posttreatment. These will include:
a. Laryngostroboscopic Examination b) Perceptual Voice Analysis/CAPE-V48-49 c) Acoustic Analysis/Computerized Speech Lab(CSL, KayPENTAX Corp) d) Aerodynamic Analysis/The KayPENTAX Phonatory Aerodynamic System (PAS) Model 6600 (KayPENTAX Corp.
e) Patients' Perception of Voice Handicap/Voice Handicap Index
Treatment Protocol Flow Phonation Each treatment session will take place in the same clinical room as the assessment and utilize three exercises: gargling, cup bubble blowing, and stretch and flow. Each exercise uses a built in form of biofeedback (water or tissue) and the same basic progression of activities (with minor alterations): 1) airflow task without voicing to establish positive airflow; 2) adding voicing to the task; 3) moving up and down the pitch range during the voicing task; 4) moving to a speaking/voicing task; and 5) removing biofeedback. During each vocalization attempt, the clinician listens for a clear and effortless vocal quality and trains the participant to listen.
Vocal Hygiene Training Vocal hygiene training centers on three factors: 1) hydration, 2) exogenous inflammation control, and 3) abstinence from yelling and screaming. Information will be provided initially as a Powerpoint presentation, during which each participant will have a manual and will write down answers to specific questions. Based on responses to the questions, the study clinician, in concert with the participant, will develop a set of recommendations for vocal hygiene. Examples of potential vocal hygiene targets are provided in Table 2. Three to five recommendations will be targeted for each participant, based on clinical judgment, although these numbers will serve only as a guide.
Participants will be provided a daily log to utilize where they can mark each target daily and make comments on how the target was met or not met. Each treatment session where Vocal Hygiene Training is targeted, alone or in concert with Airflow Training, participants will first present their goals, then provide the daily log and discuss successes and failures since the prior session. The study clinician and participant will then discuss the benefits of the successes and problem solve ways to improve upon failures.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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12 Exercise Sessions
Patients will receive 12 treatment sessions with flow phonation exercises, as well as education on vocal hygiene.
Vocal Hygiene Training
Patients will receive education on how to care for their voices on three factors: 1) hydration, 2) exogenous inflammation control, and 3) abstinence of yelling and screaming.
Flow Phonation Exercises
Three exercises are employed: gargling, cup bubble blowing, and stretch and flow (tissue blowing). Each is done without voicing, with voicing, and then with variations in pitch and verbalization.
6 Hygiene and 6 Exercise
Patients will receive 6 sessions of vocal hygiene training for initial comparison to patients in Arm 1. They will then receive 6 sessions of vocal exercise training and vocal hygiene training combined.
Vocal Hygiene Training
Patients will receive education on how to care for their voices on three factors: 1) hydration, 2) exogenous inflammation control, and 3) abstinence of yelling and screaming.
Flow Phonation Exercises
Three exercises are employed: gargling, cup bubble blowing, and stretch and flow (tissue blowing). Each is done without voicing, with voicing, and then with variations in pitch and verbalization.
Interventions
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Vocal Hygiene Training
Patients will receive education on how to care for their voices on three factors: 1) hydration, 2) exogenous inflammation control, and 3) abstinence of yelling and screaming.
Flow Phonation Exercises
Three exercises are employed: gargling, cup bubble blowing, and stretch and flow (tissue blowing). Each is done without voicing, with voicing, and then with variations in pitch and verbalization.
Eligibility Criteria
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Inclusion Criteria
* Voice Handicap Index of greater than 18
* CAPE-V severity of 20 or greater
* willing to sign informed consent
* women must not have experienced menopause or be pregnant
Exclusion Criteria
* history of neurologic disease
* history of head and neck cancer
* pulmonary disease
18 Years
55 Years
ALL
No
Sponsors
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University of Central Arkansas
OTHER
Responsible Party
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Gary H. McCullough
Professor, Interim Dean of Graduate School
Principal Investigators
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Gary H McCullough, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Central Arkansas
Locations
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University of Central Arkansas
Conway, Arkansas, United States
Countries
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Central Contacts
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Facility Contacts
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Gary H McCullough, Ph.D.
Role: primary
Other Identifiers
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13-135
Identifier Type: -
Identifier Source: org_study_id