Immersive Virtual Reality Meditation in Voice Therapy

February 2, 2026 updated by: Bradley Hoff, Icahn School of Medicine at Mount Sinai

Immediate and Cumulative Effects of Meditation on Voice Therapy Using Immersive Virtual Reality (IVR)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Mount Sinai Downtown Union Square

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Anyone not meeting inclusion criteria

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Meditation with VR
Those who receive meditation in immersive virtual reality prior to voice therapy each of the 4 sessions.
Behavioral: Voice therapy
All patients will receive a course of voice therapy as normal.
Behavioral: Meditation
Meditation at the start of each session. (each session is 30 minutes)
Device: Virtual Reality
TRIPP application in the Meta Quest 2 Virtual Reality Headset.
Experimental: Meditation without VR
Those who receive meditation with verbal guidance only prior to voice therapy each of the 4 sessions.
Behavioral: Voice therapy
All patients will receive a course of voice therapy as normal.
Behavioral: Meditation
Meditation at the start of each session. (each session is 30 minutes)
Sham Comparator: No Meditation
Those who receive standard voice therapy with no meditation.
Behavioral: Voice therapy
All patients will receive a course of voice therapy as normal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Phonation Time (MPT)
Time Frame: at each therapy session (approximately 1 week apart over 4 weeks)
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)
Time Frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
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)
Time Frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
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)
Time Frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Voice Handicap Index
Time Frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
The Voice Handicap Index (VHI) is a validated 10-item questionnaire measuring the impact of voice challenges on quality of life (QOL). Scores range from 0 to 40, with higher scores indicating greater perceived voice handicap and negative impact on daily functioning.
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
Time Frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
The State Anxiety Inventory (STAI Y-1) long form assess the severity of current state of anxiety in the moment, with a minimum score of 40 and max of 80, where scores >37 indicates moderate-severe state anxiety. Higher score indicates more severity of anxiety
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
Time Frame: Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks
The State Anxiety Inventory-Short Form (STAI Y-1) assesses severity of current state of anxiety in the moment to determine immediate effects of meditation. Scores range from 20-40. Higher score indicates more severity of anxiety.
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
Time Frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
The State Trait Anxiety Inventory (STAI Y-2) assesses severity of anxiety relative to how the patient "generally" feels. Scores range 40-80, with scores >37 indicating moderate-severe trait anxiety. Higher score indicates more severity of anxiety.
Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
Vocal Fatigue Index
Time Frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session

The Vocal Fatigue Index (VFI) is a validated questionnaire designed to measure three distinct dimensions of vocal fatigue and voice disorders. It evaluates scores across three subscales:

Fatigue and Avoidance (Part 1): Scores range from 0 to 44, with scores ≥24 indicating severity.

Physical Discomfort (Part 2): Scores range from 0 to 20, with scores ≥7 indicating severity.

Improvement with Rest (Part 3): Scores range from 0 to 12, with scores ≤7 indicating severity.

Higher scores on Parts 1 and 2, and lower scores on Part 3, indicate greater voice disorder severity. The VFI is intended to be used for the score of each subscale individually and is not validated to measure severity based on the composite score. However, the maximum total score across all three subscales is 79.
Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
CAPE-V, Consensus on Auditory-Perceptual Evaluation of Voice
Time Frame: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
A subjective auditory-perceptual evaluation to judge the severity of dysphonia from the standpoint of expert clinician raters (at least 2 for each sample, not including the treating clinician). Scale of severity overall from 0-100. Higher score indicates more severity of symptoms.
Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session
Heart rate measured in beats per minute
Time Frame: Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks
Heart rate (HR) is measured in beats per minute (bpm) using a standard hospital-provided pulse oximeter to assess cardiovascular function.
Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bradley R Hoff, MA, CCC-SLP, Icahn School of Medicine at Mount Sinai, Department of Otolaryngology
  • Study Director: Ümit Daşdöğen, Ph.D., CCC-SLP, Icahn School of Medicine at Mount Sinai, Department of Otolaryngology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY-24-01217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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