- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988207
Treating Laryngeal Hyperfunction With Flow Phonation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gary H McCullough, Ph.D.
- Phone Number: 501-450-3124
- Email: gmccullough@uca.edu
Study Locations
-
-
Arkansas
-
Conway, Arkansas, United States, 72035
- University of Central Arkansas
-
Contact:
- Gary H McCullough, Ph.D.
- Phone Number: 501-450-3124
- Email: gmccullough@uca.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 12 Exercise Sessions
Patients will receive 12 treatment sessions with flow phonation exercises, as well as education on vocal hygiene.
|
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.
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.
|
Active Comparator: 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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laryngeal Airway Resistance (Rlaw) Change Over Time
Time Frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
|
Measured using the KayPENTAX Phonatory Aerodynamic System during a voice efficiency task (i.e., repeating "apapapapapapapa."
|
3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Voice Handicap Index (VHI)
Time Frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
|
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.
|
3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
|
Consensus Auditory Perceptual Evaluation - Voice
Time Frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
|
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.
|
3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
|
Noise-to-Harmonic Ratio
Time Frame: 3 weeks, 6 weeks, 12 weeks, 3 months, 12 months
|
The KayPENTAX Computerized Speech Lab will be used to record and analyze sustained phonation (AH) and provide a measure of noise to harmonic ratio.
|
3 weeks, 6 weeks, 12 weeks, 3 months, 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gary H McCullough, Ph.D., University of Central Arkansas
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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