Effectiveness of Low-Level Light Therapy for Vocal Fatigue

NCT07062302 | Completed

• 1 other identifier: CREC2023.483
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase 2 clinical trial is to examine the effectiveness of photobiomodulation in patients with vocal fatigue. The main question it aims to answer is whether photobiomodulation is able to alleviate vocal fatigue in patients with diagnosed vocal fatigue. Participants will ask to receive photobiomodulation treatment for 12 sessions over a three week period.

Conditions

Vocal Fatigue

Keywords

vocal fatigue; voice disorders; photobiomodulation; low-level light therapy

Outcome Measures

Primary Outcomes (1)

• Vocal Fatigue Measure: Vocal Fatigue Index (VFI-HK)

  The VFI(HK) contains 19 items in three domains (i) tiredness of voice and avoidance of voice use (ii) physical discomfort and (iii) improvement of symptoms after rest. All items are rated on a scale from zero (0, meaning "never") to four (4, meaning "always"). The score ranges from 0 to 76, with higher score indicating worst outcome.

  This will be measured at baseline (pre-treatment) and within 2-weeks after the completion of treatment (post-treatment).

Secondary Outcomes (3)

• Vocal function measure: Voice Handicap Index - 30

  This will be measured at baseline (pre-treatment) and within 2-weeks after the completion of treatment (post-treatment).

• Vocal Function Measure: Aerodynamic assessment

  This will be measured at baseline (pre-treatment) and within 2-weeks after the completion of treatment (post-treatment).

• Vocal Function Measures: Acoustic voice analysis

  This will be measured at baseline (pre-treatment) and within 2-weeks after the completion of treatment (post-treatment).

Study Arms (1)

Photobiomodulation arm

EXPERIMENTAL

Device: photobiomodulation

Interventions

photobiomodulation DEVICE

The output of the photobiomodulation device is listed as below: * Irradiation size: 15 cm × 10 cm * Dual-wavelength: 660 nm + 850 nm * Optical power density: 10 - 15 mW/cm2 * Dose density: 6J/cm2

Also known as: low level light therapy

Photobiomodulation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 18 years old
• Meeting the diagnosis of vocal fatigue as per the VFI-HK
• Able to make informed consent
• Have not received any voice therapy before

You may not qualify if:

• History of photoallergy
• Significant medical or chronic diseases

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, N.T., Hong Kong

Location

Related Publications (2)

• Moreno M, Calvache C, Cantor-Cutiva LC. Systematic Review of Literature on Prevalence of Vocal Fatigue Among Teachers. J Voice. 2025 Jan;39(1):105-112. doi: 10.1016/j.jvoice.2022.07.029. Epub 2022 Sep 20.

  PMID: 36137877 BACKGROUND

• Welham NV, Maclagan MA. Vocal fatigue: current knowledge and future directions. J Voice. 2003 Mar;17(1):21-30. doi: 10.1016/s0892-1997(03)00033-x.

  PMID: 12705816 BACKGROUND

MeSH Terms

Conditions

Voice Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Photobiomodulation

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 14, 2025
• Study Start: March 9, 2024
• Primary Completion: May 12, 2024
• Study Completion: June 12, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: June 2025

Locations

HK (1)