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Voice DisordersNCT07176013

Immersive Virtual Reality Meditation in Voice Therapy

A study testing Voice therapy, Meditation and Virtual Reality in people with Voice Disorders, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Voice Disorders
What is being tested?
Voice therapy, Meditation and Virtual Reality
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
3 Sep 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Mount Sinai Downtown Union Square

    New York, New York, 10003

Other trials in United States

About this study

Official title: 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.

Conditions
Voice Disorders
Being tested
Voice therapy, Meditation, Virtual Reality
Keywords
Virtual Reality, Immersive, Mindfulness, Meditation, Voice
Medical subject headings
Voice Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Voice therapyBehavioural

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

  • MeditationBehavioural

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

  • Virtual RealityDevice

    TRIPP application in the Meta Quest 2 Virtual Reality Headset.

Study groups in NCT07176013
Study groupRoleWhat they receive
Meditation with VRExperimentalThose who receive meditation in immersive virtual reality prior to voice therapy each of the 4 sessions.
Receives: Behavioral: Voice therapy; Behavioral: Meditation; Device: Virtual Reality
Meditation without VRExperimentalThose who receive meditation with verbal guidance only prior to voice therapy each of the 4 sessions.
Receives: Behavioral: Voice therapy; Behavioral: Meditation
No MeditationSham comparatorThose who receive standard voice therapy with no meditation.
Receives: Behavioral: Voice therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (7)

  1. Voice Handicap Index

    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.

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

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

    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

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

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

    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.

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

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

    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.

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

  5. Vocal Fatigue Index

    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.

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

  6. CAPE-V, Consensus on Auditory-Perceptual Evaluation of Voice

    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.

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

  7. Heart rate measured in beats per minute

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start3 Sep 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176013
Sponsor's protocol ID
STUDY-24-01217
Status last verified
Feb 2026
First submitted
30 Jul 2025
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Questions about this trial

What is this clinical trial studying?

A study testing Voice therapy, Meditation and Virtual Reality in people with Voice Disorders, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Phonation Time (MPT) (time frame: at each therapy session (approximately 1 week apart over 4 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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