Treating Laryngeal Hyperfunction With Flow Phonation
Primary Purpose
Muscle Tension Dysphonia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vocal Hygiene Training
Flow Phonation Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Tension Dysphonia focused on measuring Muscle Tension Dysphonia, Voice, Hyperfunction
Eligibility Criteria
Inclusion Criteria:
- Rlaw greater than 1 standard deviation above or below mean
- 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:
- organic lesion of the vocal folds
- history of neurologic disease
- history of head and neck cancer
- pulmonary disease
Sites / Locations
- University of Central Arkansas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
12 Exercise Sessions
6 Hygiene and 6 Exercise
Arm Description
Patients will receive 12 treatment sessions with flow phonation exercises, as well as education on vocal hygiene.
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.
Outcomes
Primary Outcome Measures
Laryngeal Airway Resistance (Rlaw) Change Over Time
Measured using the KayPENTAX Phonatory Aerodynamic System during a voice efficiency task (i.e., repeating "apapapapapapapa."
Secondary Outcome Measures
Voice Handicap Index (VHI)
The Voice Handicap Index is a 30 item questionnaire to assess the patient's perception of the impact of their voice on their quality of life and daily functioning.
Consensus Auditory Perceptual Evaluation - Voice
The CAPE-V is a perceptual measure of voicing made by the clinician to rate the patient's vocal quality on a 100 mm line scale.
Noise-to-Harmonic Ratio
The KayPENTAX Computerized Speech Lab will be used to record and analyze sustained phonation (AH) and provide a measure of noise to harmonic ratio.
Full Information
NCT ID
NCT01988207
First Posted
September 16, 2013
Last Updated
November 13, 2013
Sponsor
University of Central Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT01988207
Brief Title
Treating Laryngeal Hyperfunction With Flow Phonation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Arkansas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purposes of the proposed study are: a) to determine whether Flow Phonation can decrease Laryngeal Resistance (Rlaw) in patients with Muscle Tension Dysphonia (MTD); and b)establish the relationship between changes in measures of Rlaw and phonatory airflow to endoscopic, perceptual, acoustic, and handicap assessment ratings. MTD can have a debilitating effect on individuals who rely on their voices the most-teachers, preachers,salespeople, singers-costing them time, money, and even their jobs. It can lead to vocal fatigue, pain, and complete loss of voice. While treatments have emerged with some promising effects, no treatments have proven to have long-term benefits to all patients. Our preliminary data demonstrate Flow Phonation training resulted in significant decreases in Laryngeal Resistance to phonatory airflow with associated improvements in voice quality and voice handicap ratings. Sample size for our pilot study was small; no control group was utilized; and outcome measures were limited. In the proposed investigation, a larger sample will be obtained, a control group of participants receiving only Vocal Hygiene Training will be used for comparison during the first 3 weeks, and a wider range of outcome measures will be included over a longer period of time (1 year).
Detailed Description
All participants will complete the Evaluation Protocol at baseline, after 3 weeks (PERIOD 1),after 6 weeks (PERIOD 2), and for follow-up at 3, 6, and 12 months post-treatment. During PERIOD 1 (first 3 weeks), participants in ARM 1 will receive Vocal Hygiene Training as well as Airflow Exercise Training and participants in ARM 2 (the Control Arm) will receive only Vocal Hygiene Training. Vocal hygiene training alone has been demonstrated to have minimal impact on voicing32-34. During Period 2 (second 3 weeks), participants in BOTH ARMS will receive Vocal Hygiene Training and Airflow Exercise Training (Fig 3). Thus, participants in Arm 2 will receive no Flow Phonation for initial controlled comparison then 3 weeks of Flow Phonation for dose response comparison to Arm 1 (non-control) participants.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tension Dysphonia
Keywords
Muscle Tension Dysphonia, Voice, Hyperfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
12 Exercise Sessions
Arm Type
Experimental
Arm Description
Patients will receive 12 treatment sessions with flow phonation exercises, as well as education on vocal hygiene.
Arm Title
6 Hygiene and 6 Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vocal Hygiene Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Flow Phonation Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Laryngeal Airway Resistance (Rlaw) Change Over Time
Description
Measured using the KayPENTAX Phonatory Aerodynamic System during a voice efficiency task (i.e., repeating "apapapapapapapa."
Time Frame
3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Voice Handicap Index (VHI)
Description
The Voice Handicap Index is a 30 item questionnaire to assess the patient's perception of the impact of their voice on their quality of life and daily functioning.
Time Frame
3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Title
Consensus Auditory Perceptual Evaluation - Voice
Description
The CAPE-V is a perceptual measure of voicing made by the clinician to rate the patient's vocal quality on a 100 mm line scale.
Time Frame
3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Title
Noise-to-Harmonic Ratio
Description
The KayPENTAX Computerized Speech Lab will be used to record and analyze sustained phonation (AH) and provide a measure of noise to harmonic ratio.
Time Frame
3 weeks, 6 weeks, 12 weeks, 3 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rlaw greater than 1 standard deviation above or below mean
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:
organic lesion of the vocal folds
history of neurologic disease
history of head and neck cancer
pulmonary disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gary H McCullough, Ph.D.
Phone
501-450-3124
Email
gmccullough@uca.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary H McCullough, Ph.D.
Organizational Affiliation
University of Central Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Central Arkansas
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72035
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary H McCullough, Ph.D.
Phone
501-450-3124
Email
gmccullough@uca.edu
12. IPD Sharing Statement
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Treating Laryngeal Hyperfunction With Flow Phonation
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