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Completed

NCT Number: NCT03416868

Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

Patients with vocal hyperfunction will undergo standard of care voice therapy with ambulatory voice monitoring before therapy and after the first 3 voice therapy sessions. Biofeedback will be added to ambulatory monitoring after the 2nd voice therapy session only.

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Key information

Conditions

Vocal Fold Nodules Muscle Tension Dysphonia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation

Boston, Massachusetts, 02114, United States

About this study

This study will use a single subject design to determine if adding ambulatory voice biofeedback to conventional voice therapy can result in faster carryover (generalization) of new vocal behaviors established during voice therapy to daily life. Here, ambulatory voice biofeedback will be based on objective measures that have subject-specific sensitivity to vocal hyperfunction. Hypothesis: The ambulatory voice biofeedback week (week 2) will result in higher generalization percentages when compared to baseline and the week prior to the initiation of biofeedback (week 1). This effect will be retained when the biofeedback is removed (week 3), thus it will be different than baseline and week 1, but not different than week 2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with vocal fold nodules or muscle tension dysphonia undergoing voice therapy

Exclusion criteria

  • If a patient's baseline ambulatory monitoring data is not at least 1 standard deviation away from a normative database in any measure, he/she will be excluded. Non-English speakers are excluded because prompts on the smartphone app are only available in English.

Treatment and study plan

Ambulatory voice biofeedback

Behavioral

Patients will be provided cues regarding their vocal behavior in daily life. Specifically, the patient will receive 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly. The specific objective voice measure for biofeedback will depend upon which measure is most strongly associated with improvements during voice therapy.

Primary outcomes

  1. Percent Compliance

    Time frame: Week 1, Week 2, Week 3

    Using a patient-specific voice measure, patients will be asked to avoid crossing numeric thresholds. The amount of voicing spent within desired thresholds will be the "percent compliance".

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2018
Registry last updated
Apr 17, 2024

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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