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.
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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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
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
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 group | Role | What they receive |
|---|---|---|
| Meditation with VR | Experimental | Those 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 VR | Experimental | Those who receive meditation with verbal guidance only prior to voice therapy each of the 4 sessions. Receives: Behavioral: Voice therapy; Behavioral: Meditation |
| No Meditation | Sham comparator | Those 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.
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)
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
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
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)
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
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
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
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
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
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
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.
- First posted16 Sep 2025
- Study start3 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Hoff, Icahn School of Medicine at Mount Sinai
- Investigators
- Bradley R Hoff, MA, CCC-SLP, Principal investigator, Icahn School of Medicine at Mount Sinai, Department of OtolaryngologyÜmit Daşdöğen, Ph.D., CCC-SLP, Study director, Icahn School of Medicine at Mount Sinai, Department of Otolaryngology
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).