Vocal Cord Strain (Disorder)NCT07879040
The Impact of Hyperbaric Oxygen Therapy on Vocal Performance in Professional Singers
A study testing Device: hyperbaric oxygen therapy in people with Vocal Cord Strain (Disorder), run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The aim of the current study is to evaluate the Impact of Hyperbaric Oxygen Therapy on Vocal Performance in Professional Singers Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vocal Cord Strain (Disorder)
- What is being tested?
- Device: hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Mar 2025to 30 Dec 2030
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-70
- Professional singers for at least 3 months.
- Subject willing and able to read, understand and sign an informed consent.
Who cannot join
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Substance use at baseline.
- Any sever illness that based on the physician expected to deteriorate in the upcoming year.
- HBOT for any reason prior to study enrolment
- Chest pathology incompatible with pressure changes (including active asthma or COPD)
- Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
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- An inability to perform an awake brain MRI
- Active smoking
- Participation in another study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Assaf-Harofeh Medical Center
Tsrifin, 70300
Shai efrati, MD, 972-549-212-866, efratishai@013.net
About this study
Official title: The Impact of Hyperbaric Oxygen Therapy (HBOT) on Vocal Performance in Professional Singers: A Prospective, Randomized, Controlled Clinical Trial
The aim of the current study is to evaluate the Impact of Hyperbaric Oxygen Therapy on Vocal Performance in Professional Singers
Read the detailed description
Professional singers frequently face occupational risks that affect the health and function of their vocal folds. Vocal fold pathologies such as vocal folds edema, nodules, polyps, laryngitis, and muscle tension dysphonia are common among singers and can lead to significant alterations in voice quality and performance endurance. Traditional therapeutic approaches often include voice rest, vocal training, and in some cases, pharmacological interventions or surgery. However, these methods can be either only partially effective, require extended downtime, which is impractical for professional singers, or expose the singer to potentially significant side effects as in the case of the commonly used steroids interventions.
Hyperbaric oxygen therapy (HBOT) has emerged as a potential innovative treatment for enhancing tissue healing and managing various medical conditions. Research has demonstrated HBOT\'s efficacy in enhancing tissue repair and modulating inflammatory responses, making it a compelling candidate for treating vocal fold injuries. Despite its potential, the application of HBOT in improving vocal fold function has not been thoroughly investigated. This study aims to fill this gap by evaluating the effectiveness of HBOT in enhancing vocal performance, through a prospective, randomized, controlled design. This research will provide robust evidence of the potential benefits of HBOT, offering an alternative or adjunct therapy that could improve the management of vocal health in the singing profession.
In the following text, we will review the physiology of the vocal folds, the common pathophysiology in professional singers, and the physiological effect of the new protocols of HBOT.
- Conditions
- Vocal Cord Strain (Disorder)
- Being tested
- Device: hyperbaric oxygen therapy
- Keywords
- hyperbaric oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: hyperbaric oxygen therapyDevice
The HBOT protocol consists of 40 daily sessions, five times per week, each session lasting 90 minutes. Investigational product: Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: hyperbaric oxygen therapy (HBOT) active treatment | Experimental | The HBOT protocol consists of 40 daily sessions, five times per week, within a three months' period. Then there will be a follow-up period for 3 months without any investigated intervention. each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes. Receives: Device: Device: hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal performance tests
The primary endpoint will be based on the evaluation of the voice recordings using the following measurement :Fundamental frequency (F0) : Mean F0 = average pitch across the sample Maximum F0 = highest pitch reached Minimum F0 = lowest pitch reached Units Hertz (Hz)
Measured: Change from Baseline immediately after the intervention
Secondary outcomes (8)
Stroboscopy
Participants would be asked to have larynx anatomic and functional evaluation performed by an otolaryngologist, using a laryngeal stroboscopy system. evaluation of vocal fold vibration and reveals subtle vocal fold pathologies, such as vocal fold scars which could be easily missed by using constant light laryngoscopy.
Measured: only at baseline and after the last HBOT sessions
singing ability Questionnaire
The Singers Voice Handicap Index (Singers VHI) is a self-assessment questionnaire used to evaluate the impact of voice disorders on the participant quality of life. It consists of 36 questions scored on a scale from 0 to 4 , that assess various aspects of vocal function (physical, functional, and emotional)
Measured: Change from Baseline immediately after the intervention
Short form health survey (sf-36)
Assessment of health-related quality of life with the SF-36 Health Survey. Quality of life questionnaire, scale of 0-100, higher score means better outcome
Measured: Change from Baseline immediately after the intervention
Vocal Range
The span between the lowest and highest producible pitches. The span between the lowest and highest producible pitches.
Measured: Change from Baseline immediately after the intervention
Jitter (cycle-to-cycle variations in pitch)
Small cycle-to-cycle irregularities in frequency/pitch during vocal fold vibration.
Measurements Needed Duration/frequency of consecutive vibratory cycles Variation between one cycle and the next Units Percent (%) Microseconds (µs)
Measured: Change from Baseline immediately after the intervention
Shimmer (cycle-to-cycle variations in amplitude)
Cycle-to-cycle irregularity in loudness/amplitude.
Measurements Needed Amplitude of each glottal cycle Differences between adjacent cycles Units Percent (%) Decibels (dB)
Measured: Change from Baseline immediately after the intervention
Harmonics-to-Noise Ratio (HNR)
Ratio of periodic harmonic energy (clear vocal tone) to aperiodic noise energy (breathiness/roughness).
Measurements Needed Harmonic signal energy Noise component energy Units Decibels (dB) Meaning Higher HNR = clearer/healthier voice Lower HNR = noisier/hoarser voice
Measured: Change from Baseline immediately after the intervention
Maximum Phonation Time (MPT)
Longest duration a person can sustain a vowel (usually /a/) on one breath. Measurements Needed Deep inhalation Sustain vowel at comfortable pitch/loudness Measure time until phonation stops Units Seconds
Measured: Change from Baseline immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start30 Mar 2025
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord Strain (Disorder)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Hyperbaric oxygen therapy (2ATA, 100% oxygen)
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shai Efrati, Prof, Study director, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879040
- Sponsor's protocol ID
- 0098-24
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hyperbaric Oxygen Therapy (HBOT) on Vocal Performance in Professional Singers: A Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07879040
- Acronym / sponsor ID
- 0098-24
- Conditions
- Vocal Cord Strain (Disorder)
- Keywords
- hyperbaric oxygen therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to evaluate the Impact of Hyperbaric Oxygen Therapy on Vocal Performance in Professional Singers
Detailed description
Professional singers frequently face occupational risks that affect the health and function of their vocal folds. Vocal fold pathologies such as vocal folds edema, nodules, polyps, laryngitis, and muscle tension dysphonia are common among singers and can lead to significant alterations in voice quality and performance endurance. Traditional therapeutic approaches often include voice rest, vocal training, and in some cases, pharmacological interventions or surgery. However, these methods can be either only partially effective, require extended downtime, which is impractical for professional singers, or expose the singer to potentially significant side effects as in the case of the commonly used steroids interventions.
Hyperbaric oxygen therapy (HBOT) has emerged as a potential innovative treatment for enhancing tissue healing and managing various medical conditions. Research has demonstrated HBOT\'s efficacy in enhancing tissue repair and modulating inflammatory responses, making it a compelling candidate for treating vocal fold injuries. Despite its potential, the application of HBOT in improving vocal fold function has not been thoroughly investigated. This study aims to fill this gap by evaluating the effectiveness of HBOT in enhancing vocal performance, through a prospective, randomized, controlled design. This research will provide robust evidence of the potential benefits of HBOT, offering an alternative or adjunct therapy that could improve the management of vocal health in the singing profession.
In the following text, we will review the physiology of the vocal folds, the common pathophysiology in professional singers, and the physiological effect of the new protocols of HBOT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hyperbaric oxygen therapy (2ATA, 100% oxygen)
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: hyperbaric oxygen therapy (HBOT) active treatment | Experimental | Device: Device: hyperbaric oxygen therapyThe HBOT protocol consists of 40 daily sessions, five times per week, within a three months' period. Then there will be a follow-up period for 3 months without any investigated intervention. each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-70
- Professional singers for at least 3 months.
- Subject willing and able to read, understand and sign an informed consent.
Key exclusion criteria (9 listed)
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Substance use at baseline.
- Any sever illness that based on the physician expected to deteriorate in the upcoming year.
- HBOT for any reason prior to study enrolment
- Chest pathology incompatible with pressure changes (including active asthma or COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: hyperbaric oxygen therapyThe HBOT protocol consists of 40 daily sessions, five times per week, each session lasting 90 minutes. Investigational product: Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel. | Device | Active Comparator: hyperbaric oxygen therapy (HBOT) active treatment |
Primary outcome
Vocal performance tests
Time frame: Change from Baseline immediately after the intervention
The primary endpoint will be based on the evaluation of the voice recordings using the following measurement :Fundamental frequency (F0) : Mean F0 = average pitch across the sample Maximum F0 = highest pitch reached Minimum F0 = lowest pitch reached Units Hertz (Hz)
8 secondary outcomes
Stroboscopy
Time frame: only at baseline and after the last HBOT sessions
singing ability Questionnaire
Time frame: Change from Baseline immediately after the intervention
Short form health survey (sf-36)
Time frame: Change from Baseline immediately after the intervention
Vocal Range
Time frame: Change from Baseline immediately after the intervention
Jitter (cycle-to-cycle variations in pitch)
Time frame: Change from Baseline immediately after the intervention
Shimmer (cycle-to-cycle variations in amplitude)
Time frame: Change from Baseline immediately after the intervention
Harmonics-to-Noise Ratio (HNR)
Time frame: Change from Baseline immediately after the intervention
Maximum Phonation Time (MPT)
Time frame: Change from Baseline immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shai Efrati, Prof study director
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: hyperbaric oxygen therapy in people with Vocal Cord Strain (Disorder), run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Oct 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 Israel. 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. 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?
Contact Shai Efrati, Prof (+972-8-9779393, efratishai@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal performance tests (time frame: Change from Baseline immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.