Treating Laryngeal Hyperfunction With Flow Phonation

NCT01988207 | Unknown DMC

• 1 other identifier: 13-135
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Muscle Tension Dysphonia

Keywords

Muscle Tension Dysphonia; Voice; Hyperfunction

Outcome Measures

Primary Outcomes (1)

• Laryngeal Airway Resistance (Rlaw) Change Over Time

  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 Outcomes (3)

• Voice Handicap Index (VHI)

  3 weeks, 6 weeks, 12 weeks, 6 months, 12 months

• Consensus Auditory Perceptual Evaluation - Voice

  3 weeks, 6 weeks, 12 weeks, 6 months, 12 months

• Noise-to-Harmonic Ratio

  3 weeks, 6 weeks, 12 weeks, 3 months, 12 months

Study Arms (2)

12 Exercise Sessions

EXPERIMENTAL

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

6 Hygiene and 6 Exercise

ACTIVE COMPARATOR

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

Interventions

Vocal Hygiene Training BEHAVIORAL

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.

12 Exercise Sessions; 6 Hygiene and 6 Exercise

Flow Phonation Exercises BEHAVIORAL

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.

12 Exercise Sessions; 6 Hygiene and 6 Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• organic lesion of the vocal folds
• history of neurologic disease
• history of head and neck cancer
• pulmonary disease

Sponsors & Collaborators

• University of Central Arkansas: lead

Study Sites (1)

University of Central Arkansas

Conway, Arkansas, 72035, United States

Location

Study Officials

• Gary H McCullough, Ph.D.

  University of Central Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary H McCullough, Ph.D.

CONTACT

501-450-3124; gmccullough@uca.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Interim Dean of Graduate School

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

US (1)