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Immersive Virtual Reality Meditation in Voice Therapy

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What is being tested

Voice therapy

+ Meditation
+ Virtual Reality
Behavioral
Device
Who is being recruted

Voice Disorders

Over 18 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2025

See protocol details

Summary

Principal SponsorIcahn School of Medicine at Mount Sinai
Study ContactBradley R Hoff, MA, CCC-SLP
Last updated: September 16, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: March 3, 2025Actual date on which the first participant was enrolled.

The study is investigating if using guided meditation through immersive virtual reality (IVR) can improve voice therapy sessions. It focuses on 30 participants who will use the TRIPP application with the Meta Quest 2 virtual reality headset. This technology is famous for providing calming or focusing meditation experiences. The goal is to see if starting voice therapy with these meditations can help people learn and remember the therapy techniques better. This research is important because stress and anxiety can make voice therapy less effective, and finding ways to enhance therapy through IVR could help people manage their vocal issues more successfully. In the study, participants will use the virtual reality headset at the beginning of their voice therapy sessions to engage in guided meditation. This approach aims to improve their attention, self-control, and reduce excessive strain on their voices. The study will evaluate how these meditations impact vocal production and therapy engagement. Although specific risks or benefits are not mentioned, the research hopes to show that incorporating meditation in this way can enhance therapy outcomes by helping participants focus better and manage their stress, potentially leading to better voice control and therapy results.

Official TitleImmediate and Cumulative Effects of Meditation on Voice Therapy Using Immersive Virtual Reality (IVR) 
Principal SponsorIcahn School of Medicine at Mount Sinai
Study ContactBradley R Hoff, MA, CCC-SLP
Last updated: September 16, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Voice Disorders
Criteria
2 inclusion criteria required to participate
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
6 exclusion criteria prevent from participating
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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Those who receive meditation in immersive virtual reality prior to voice therapy each of the 4 sessions.
Group II
Experimental
Those who receive meditation with verbal guidance only prior to voice therapy each of the 4 sessions.
Group III
Sham
Those who receive standard voice therapy with no meditation.
Study Objectives
Primary Objectives

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.

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.

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.

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.
Secondary Objectives

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.

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

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.

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.

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.

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.

Heart rate (HR) is measured in beats per minute (bpm) using a standard hospital-provided pulse oximeter to assess cardiovascular function.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
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Mount Sinai Downtown Union SquareNew York, United StatesSee the location
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One Study Center