An interventional study of Vocal Hygiene Training and Flow Phonation Exercises in Muscle Tension Dysphonia, sponsored by University of Central Arkansas. Status unknown at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-11-20.
Sponsored by University of Central Arkansas · Not applicable, Interventional, and Treatment
Among 71 studies in Dysphonia with a site in United States — 20 open to participants now, 21 under way, 1 of them phase 3. Dysphonia · United States.
Among the 71 studies in Dysphonia with a site in United States, this one is the 17th largest by planned enrollment of the 53 interventional ones, is one of 3 that started in 2013, is one of 31 with no phase, and was the 17th registered.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 60 is above the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →20 of the 71 studies in Dysphonia with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 25 Dysphonia studies recruiting now, 8 (32%) set no upper age limit and 9 (36%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →71 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 3 started in 2013.
Median enrollment 32 across the 53 interventional studies, 170 across the 18 observational. Of the 41 that completed or were terminated, 17 (41%) have results posted.
2 of 71 have an industry lead sponsor. The 10 most frequent:
University of Central Arkansas is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
University of Central Arkansas has 1 study filed under Dysphonia — fewer than ten, so there is no comparison to draw.
12 of the studies in Dysphonia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07145086Phase 3Texas Christian UniversityTranslaryngeal Vibration for Hyperfunctional Voice Disorders | 2027-04-30 |
| NCT06830174Yale UniversitytDCS for Laryngeal Dystonia | 2026-12 |
| NCT03702322University of ArizonaImproving Voice Production for Adults With Age-related Dysphonia | 2026-12-30 |
| NCT05095740MGH Institute of Health ProfessionsEffects of Neuromodulation in Laryngeal Dystonia | 2026-12-31 |
| NCT07443891University of MinnesotaBrain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia | 2027-02-28 |
Among the 71 studies in Dysphonia with a site in United States, from their registry updates:
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive 12 treatment sessions with flow phonation exercises, as well as education on vocal hygiene.
Behavioral: Vocal Hygiene Training · Behavioral: Flow Phonation Exercises
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.
Behavioral: Vocal Hygiene Training · Behavioral: Flow Phonation Exercises
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.
Laryngeal Airway Resistance (Rlaw) Change Over Time
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
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.
Time frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
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.
Time frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
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.
Time frame: 3 weeks, 6 weeks, 12 weeks, 3 months, 12 months
The record gives a start of Dec 2013, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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University of Central Arkansas