Immersive Virtual Reality Meditation in Voice Therapy

NCT07176013 | Enrolling By Invitation

• 1 other identifier: STUDY-24-01217
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the feasibility of incorporating regular guided meditations via immersive virtual reality (IVR) at the start of voice therapy sessions to facilitate better learning and retention of treatment. The study will involve 30 participants, and use the TRIPP application with the Meta Quest 2 virtual reality headset, known for its immersive meditation experiences designed to calm or focus the user. The objective is to investigate the immediate effects of meditation/mindfulness in IVR on vocal production, with the goal of improving self-regulation, attentional focus, and reducing vocal hyperfunction. IVR has been utilized in mental health settings and exposure therapy for various conditions, but its application in voice therapy, particularly for anxiety reduction through fully immersive meditation, remains unexplored. The study seeks to determine whether IVR can enhance therapy outcomes by improving engagement, attention, and vocal control in individuals undergoing voice therapy, potentially maximizing treatment gains. Through this research, the aim is to assess the efficacy of IVR in enhancing voice therapy interventions and addressing the unique challenges posed by stress and anxiety in voice users.

Conditions

Voice Disorders

Keywords

Virtual Reality; Immersive; Mindfulness; Meditation; Voice

Outcome Measures

Primary Outcomes (4)

• Maximum Phonation Time (MPT)

  MPT will be used to assess participants' maximum phonation time. The speech evaluator instructs the patient to take a comfortable breath and then produce the sound /a/ for as long as possible. The task is performed twice, and the maximum duration of the two measurements is used.

  at each therapy session (approximately 1 week apart over 4 weeks)

• Noise-to-Harmonic Ratio (NHR)

  NHR is a parameter in MDVP that represents ratio of non-harmonic and harmonic waves in a certain sound wave period. NHR describes the quality of the amount of noise in the sound. Inadequate closure of the vocal cords and periodic vibrations of the vocal cords cause excessive air flow as it passes through the vocal cords, causing turbulence and noise. Normal and periodic sound signals will have a small NHR, while dysphonia sound signals will have a large NHR value.

  Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session

• Cepstral Peak Prominence (CPPS)

  Cepstral Peak Prominence (CPPS) is an indicator of voice quality. It is measured in decibels. An increase in CPPS value indicates an improvement in voice symptoms.

  Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session

• Acoustic Vocal Quality Index (AVQI)

  The acoustic voice quality index (AVQI) is a multiparametric score to quantify vocal quality. It is based on a weighted combination of 6 voice parameters: smoothed cepstral peak prominence (CPPS), harmonics-to-noise ratio (HNR), shimmer local (SL), shimmer local dB (SLdB), general slope of the spectrum (slope) and tilt of the regression line through the spectrum (tilt). The formula is constructed as 9.072 - 0.245 × CPPs - 0.161 × HNR - 0.470 × SL + 6.158 × SLdB - 0.071 × Slope - 0.170 × Tilt and ranges from 0 to 10. A lower score correlates with a better vocal quality.

  Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session

Secondary Outcomes (7)

• Voice Handicap Index

  Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session

• State Trait Anxiety Inventory Y-1 (STAI-1), long form

  Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session

• State Trait Anxiety Inventory Y-1 (STAY Y-1), short form

  Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks

• State Trait Anxiety Inventory Y-2 (STAI Y-2), long form

  Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session

• Vocal Fatigue Index

  Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session

Study Arms (3)

Meditation with VR

EXPERIMENTAL

Those who receive meditation in immersive virtual reality prior to voice therapy each of the 4 sessions.

Behavioral: Voice therapy; Behavioral: Meditation; Device: Virtual Reality

Meditation without VR

EXPERIMENTAL

Those who receive meditation with verbal guidance only prior to voice therapy each of the 4 sessions.

Behavioral: Voice therapy; Behavioral: Meditation

No Meditation

SHAM COMPARATOR

Those who receive standard voice therapy with no meditation.

Behavioral: Voice therapy

Interventions

Voice therapy BEHAVIORAL

All patients will receive a course of voice therapy as normal.

Meditation with VR; Meditation without VR; No Meditation

Meditation BEHAVIORAL

Meditation at the start of each session. (each session is 30 minutes)

Meditation with VR; Meditation without VR

Virtual Reality DEVICE

TRIPP application in the Meta Quest 2 Virtual Reality Headset.

Meditation with VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with voice disorders, difficulties or laryngeal hypersensitivity, and who also have anxiety
• Must have availability to participate for entire course of 5 consistent weeks

You may not qualify if:

• Presence of any additional medical condition significantly affecting:
• Respiratory function (e.g., advanced lung disease)
• Laryngeal function (e.g., status-post deep brain stimulation)
• Lingual function
• Velopharyngeal function (e.g., laryngectomy)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Downtown Union Square

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Voice Disorders

Interventions

Meditation

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)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bradley R Hoff, MA, CCC-SLP

  Icahn School of Medicine at Mount Sinai, Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

• Ümit Daşdöğen, Ph.D., CCC-SLP

  Icahn School of Medicine at Mount Sinai, Department of Otolaryngology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speech-Language Pathologist

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: September 16, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be determined).

Locations

US (1)