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Completed

NCT Number: NCT02922309

Comparing Telepractice and Conventional Face-to-face Voice Therapy

People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. However, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus reduces treatment effects. The purpose of the study is to design a telecommunication vocal training system and a vocal training program for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study, including a single-blind, randomized controlled trial, to test the hypothesis that vocal training via telepractice for voice disordered elderly are not inferior to the standard face to face training.

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Key information

Conditions

Dysphonia Aged Communication Disorders Laryngeal Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Speech Therapy Voice Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Randomization: per mutated block, 40 patients on each arms (experimental and control)

Allocation: sealed envelope indicating either of the 2 groups

Intervention: weekly vocal training, each course last for 30-40 minutes,lasting for 2 months

Outcome measurement: before treatment, 1 month, 3 months, and 6 months after treatment

Primary outcome: 10-item voice handicap index

Secondary outcome: acoustics and aerodynamic parameter

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient equal or older than 55 years old
  • Voice Handicap Index-10 (VHI-10) score >10 point
  • accessibility to a network connection

Exclusion criteria

  • neurologic disorders
  • active pulomanory disease
  • mental disorder

Treatment and study plan

Vocal Training Via Telepractice

Behavioral

Vocal Training Via Telepractice, delivered by integrated communication service

Vocal Training Via face-to face practice

Behavioral

Vocal Training Via face-to face practice at medical facilities

Primary outcomes

  1. Change from Baseline of 10-item voice handicap index at 2 months

    Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    min: 0(best); Max: 40(worst);

Other outcomes

  1. Perceptual Analysis using grade, roughness, breathiness, asthenia, and strain

    Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    from 0(best) to 3(worst)

  2. Jitter

    Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    percentage of jitter based on continuous vowel

  3. Shimmer

    Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    decibel (dB) of shimmer based on continuous vowel

  4. Noise to harmonic ratio

    Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    Noise to harmonic ratio based on continuous vowel

  5. smoothed Cepstrum peak prominence

    Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    based on reading a Mandarin passage

  6. Maximal phonation time

    Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    seconds

  7. VLS

    Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy

    Videolaryngostroboscopy (mucosal wave: normal, mildly decreased, severely decreased, absent)

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-face Therapy

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2016
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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