SingingNCT07007845
The Effect of Osteopathy and Complete Vocal Technique on Phonation in Amateur Singers
A study testing CVT Support intervention and Dooming Diaphragm in people with Singing and Breathing Exercise, run by Complete Vocal Institute at 1 site in Denmark.
Trial summary
This study is about breathing function during singing, specifically aimed at improving the functionof the muscles in the respiratory system involved in control over the voice.The goal of the study is to examine if osteopathic techniques and/or work with support developedby Complete Vocal Institute influences voice… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Singing, Breathing Exercise, Osteopathy
- What is being tested?
- CVT Support intervention and Dooming Diaphragm
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Mar 2025to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General health, no known vocal pathology or ongoing respiratory infection
- No ongoing reflux symptoms
- Amateur singer
Who cannot join
- No prior osteopathic treatment related to voice
- No prior CVT Support Training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Osteopathy and Complete Vocal Technique on Phonation in Amateur Singers: A Crossover Study.
This study is about breathing function during singing, specifically aimed at improving the functionof the muscles in the respiratory system involved in control over the voice.The goal of the study is to examine if osteopathic techniques and/or work with support developedby Complete Vocal Institute influences voice quality and sense of ease using voice.The study compares two types of interventions:1: An osteopathic optimization treatment for diaphragm, a major muscle responsible for breathing.And2: A singing technique for learning stamina.Both techniques work on improving patterns of breathing which should make singing feel easier and lower future risks of injury and strain. The study takes place at Complete Vocal Institute where participant voices will be recorded by a microphone and by a laryngograph. In using the laryngograph, two gold-plated electrodes will be placed over the larynx. A microphone records the voice whereas EGG-electrodes record how the vocal folds are vibrating. Measurements are made before each type of treatment and after each treatment. Both are non-invasive and carry no risk to the voice. The recordings will be done in a sound-treated room for privacy.The singing intervention will involve breathing exercises, and the osteopathic treatment will involve a single fascia treatment. It is possible that the osteopathic treatment can leave participant diaphragms and the area around the lower ribs sore, this is normal and is expected to last no more than 24-48 hours. Each session is expected to last approximately one hour, and only a single visit will be required.To ensure comfort, please wear loose-fitting clothing that allows for easy breathing and singing. For one part of the intervention, participants will be asked to remove clothing like one would for any physical massage, so the therapist can access and treat the diaphragm.There are no costs involved nor compensation for participation in the study. Participation is completely voluntary. Should participants at any time wish to withdraw from the study, they are free to do so by informing Julie Bie at julie@netfyssen.dk hereof.All data will be anonymized and any information that could identify participants as a subject will be kept strictly confidential. No personal information will be included in the study report or other publication arising from the project analysis.If there have any questions, please contact the investigators at julie@netfyssen.dk or mathias@shout.dk. This research is being overseen by an Institutional Review Board ("IRB"). The two therapists involved in this study are insured, and the study has received favorable approval from the Ethics Committee of Buckinghamshire New University.
- Conditions
- Singing, Breathing Exercise, Osteopathy
- Being tested
- CVT Support intervention, Dooming Diaphragm
- Keywords
- Diaphragm function, Singing technique, Support, Osteopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVT Support interventionBehavioural
Also called CVT Support
The CVT Emergency Aid program focused on optimising the work on the diaphragm was conducted in 3 steps. Step 1 related to establishing diaphragmatic breathing by feeling expansion around lower ribs at inhalation. Step 2 related to establishing connection between pulmonary pressure and subtotal pressurisation by invoking inwards abdominal movements on controlled exhaled voiceless exercises (ssss-sound) Step 3 related to establishing dynamic control of subglottal pressure by performing fricative voice sounds (vvvf- and zzz-sounds) while contracting the abdominal wall inwards and thereby pressurising the pulmonary space leading to increased subglottal pressure on accents and extended pitch accents.
Dooming DiaphragmProcedure or surgery
Also called Osteopathic treatment of diaphragm
Osteopathic treatment: Dooming Diaphragm. The inferior costal margin was contacted with the hands, allowing the thumbs to rest just below the ribcage anteriorly. Care was taken to avoid contact with the xiphoid process, as this could cause discomfort for the patient. The patient was instructed to breathe deeply, and as they exhaled, gentle pressure was applied superiorly and laterally with the thumbs, rolling them underneath the ribcage as far as was comfortable. This process was repeated for 3-5 breath cycles or until no tension was felt in the thumbs during exhalation.
| Study group | Role | What they receive |
|---|---|---|
| CVT Support optimisation | Active comparator | The CVT Emergency Aid program focused on optimising the work on the diaphragm was conducted in 3 steps.
Step 1 related to establishing diaphragmatic breathing by feeling expansion around lower ribs at inhalation.
Step 2 related to establishing connection between pulmonary pressure and subtotal pressurisation by invoking inwards abdominal movements on controlled exhaled voiceless exercises (ssss-sound) Step 3 related to establishing dynamic control of subglottal pressure by performing fricative voice sounds (vvvf- and zzz-sounds) while contracting the abdominal wall inwards and thereby pressurising the pulmonary space leading to increased subglottal pressure on accents and extended pitch accents. Receives: Behavioral: CVT Support intervention |
| Osteopathy | Experimental | Osteopathic treatment: Dooming Diaphragm. The inferior costal margin was contacted with the hands, allowing the thumbs to rest just below the ribcage anteriorly. Care was taken to avoid contact with the xiphoid process, as this could cause discomfort for the patient. The patient was instructed to breathe deeply, and as they exhaled, gentle pressure was applied superiorly and laterally with the thumbs, rolling them underneath the ribcage as far as was comfortable. This process was repeated for 3-5 breath cycles or until no tension was felt in the thumbs during exhalation. Receives: Procedure: Dooming Diaphragm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Phonation Time
The total amount in seconds a sustained phonation can be maintained
Measured: Baseline
Mean sound pressure level
Sound pressure level, SPL, to indicate vocal loudness.
Measured: Baseline
Maximum and minimum fundamental frequency
The maximum and minimum fundamental frequency as an indicator of singing note pitch.
Measured: Baseline
Fx SD
Fundamental Frequency Standard Deviation (Fx SD)
Measured: Baseline
Qx
Average Contact Quotient (Qx)
Measured: Baseline
Jitter
Amount (in %) of Jitter during cycle to cycle variation of vocal fold oscillations on a sustained vowel measured by electroglottography
Measured: Baseline
Normalised Noise Energy
Normalised Noise Energy (NNE) of acoustic radiated output during phonation
Measured: Baseline
Cepstral Peak Prominence
Cepstral Peak Prominence (CPP) of sustained phonation
Measured: Baseline
Maximum Phonation Time
The total amount in seconds a sustained phonation can be maintained
Measured: Day 1
Mean sound pressure level
Sound pressure level, SPL, to indicate vocal loudness.
Measured: Day 1
Maximum and minimum fundamental frequency
The maximum and minimum fundamental frequency as an indicator of singing note pitch.
Measured: Day 1
Fx SD
Fundamental Frequency Standard Deviation (Fx SD)
Measured: Day 1
Qx
Average Contact Quotient (Qx)
Measured: Day 1
Jitter
Amount (in %) of Jitter during cycle to cycle variation of vocal fold oscillations on a sustained vowel measured by electroglottography
Measured: Day 1
Normalised Noise Energy
Normalised Noise Energy (NNE) of acoustic radiated output during phonation
Measured: Day 1
Cepstral Peak Prominence
Cepstral Peak Prominence (CPP) of sustained phonation
Measured: Day 1
Maximum Phonation Time - post intervention
The total amount in seconds a sustained phonation can be maintained
Measured: Day 1
Mean sound pressure level - post intervention
Sound pressure level, SPL, to indicate vocal loudness.
Measured: Day 1
Maximum and minimum fundamental frequency - post intervention
The maximum and minimum fundamental frequency as an indicator of singing note pitch.
Measured: Day 1
Fx SD - post intervention
Fundamental Frequency Standard Deviation (Fx SD)
Measured: Day 1
Qx - post intervention
Average Contact Quotient (Qx)
Measured: Day 1
Jitter - post intervention
Amount (in %) of Jitter during cycle to cycle variation of vocal fold oscillations on a sustained vowel measured by electroglottography
Measured: Day 1
Normalised Noise Energy - post intervention
Normalised Noise Energy (NNE) of acoustic radiated output during phonation
Measured: Day 1
Cepstral Peak Prominence - post intervention
Cepstral Peak Prominence (CPP) of sustained phonation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start3 Mar 2025
- Primary completion7 Mar 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SingingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complete Vocal Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Buckinghamshire New University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007845
- Sponsor's protocol ID
- CVT Support and Osteopathy
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To respect the anonymity of study participants, data will not be shared beyond reasonable request that ensures privacy and GDPR compliance.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathy and Complete Vocal Technique on Phonation in Amateur Singers: A Crossover Study.
- ClinicalTrials.gov ID
- NCT07007845
- Acronym / sponsor ID
- CVT Support and Osteopathy
- Conditions
- Singing, Breathing Exercise, Osteopathy
- Keywords
- Diaphragm function, Singing technique, Support, Osteopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Complete Vocal InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Buckinghamshire New University
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 6 Jun 2025 (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.
This study is about breathing function during singing, specifically aimed at improving the functionof the muscles in the respiratory system involved in control over the voice.The goal of the study is to examine if osteopathic techniques and/or work with support developedby Complete Vocal Institute influences voice quality and sense of ease using voice.The study compares two types of interventions:1: An osteopathic optimization treatment for diaphragm, a major muscle responsible for breathing.And2: A singing technique for learning stamina.Both techniques work on improving patterns of breathing which should make singing feel easier and lower future risks of injury and strain. The study takes place at Complete Vocal Institute where participant voices will be recorded by a microphone and by a laryngograph. In using the laryngograph, two gold-plated electrodes will be placed over the larynx. A microphone records the voice whereas EGG-electrodes record how the vocal folds are vibrating. Measurements are made before each type of treatment and after each treatment. Both are non-invasive and carry no risk to the voice. The recordings will be done in a sound-treated room for privacy.The singing intervention will involve breathing exercises, and the osteopathic treatment will involve a single fascia treatment. It is possible that the osteopathic treatment can leave participant diaphragms and the area around the lower ribs sore, this is normal and is expected to last no more than 24-48 hours. Each session is expected to last approximately one hour, and only a single visit will be required.To ensure comfort, please wear loose-fitting clothing that allows for easy breathing and singing. For one part of the intervention, participants will be asked to remove clothing like one would for any physical massage, so the therapist can access and treat the diaphragm.There are no costs involved nor compensation for participation in the study. Participation is completely voluntary. Should participants at any time wish to withdraw from the study, they are free to do so by informing Julie Bie at julie@netfyssen.dk hereof.All data will be anonymized and any information that could identify participants as a subject will be kept strictly confidential. No personal information will be included in the study report or other publication arising from the project analysis.If there have any questions, please contact the investigators at julie@netfyssen.dk or mathias@shout.dk. This research is being overseen by an Institutional Review Board ("IRB"). The two therapists involved in this study are insured, and the study has received favorable approval from the Ethics Committee of Buckinghamshire New University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVT Support optimisation | Active comparator | Behavioral: CVT Support interventionThe CVT Emergency Aid program focused on optimising the work on the diaphragm was conducted in 3 steps. Step 1 related to establishing diaphragmatic breathing by feeling expansion around lower ribs at inhalation. Step 2 related to establishing connection between pulmonary pressure and subtotal pressurisation by invoking inwards abdominal movements on controlled exhaled voiceless exercises (ssss-sound) Step 3 related to establishing dynamic control of subglottal pressure by performing fricative voice sounds (vvvf- and zzz-sounds) while contracting the abdominal wall inwards and thereby pressurising the pulmonary space leading to increased subglottal pressure on accents and extended pitch accents. |
| Osteopathy | Experimental | Procedure: Dooming DiaphragmOsteopathic treatment: Dooming Diaphragm. The inferior costal margin was contacted with the hands, allowing the thumbs to rest just below the ribcage anteriorly. Care was taken to avoid contact with the xiphoid process, as this could cause discomfort for the patient. The patient was instructed to breathe deeply, and as they exhaled, gentle pressure was applied superiorly and laterally with the thumbs, rolling them underneath the ribcage as far as was comfortable. This process was repeated for 3-5 breath cycles or until no tension was felt in the thumbs during exhalation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- General health, no known vocal pathology or ongoing respiratory infection
- No ongoing reflux symptoms
- Amateur singer
Key exclusion criteria (2 listed)
- No prior osteopathic treatment related to voice
- No prior CVT Support Training
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 |
|---|---|---|
| CVT Support interventionAlso: CVT SupportThe CVT Emergency Aid program focused on optimising the work on the diaphragm was conducted in 3 steps. Step 1 related to establishing diaphragmatic breathing by feeling expansion around lower ribs at inhalation. Step 2 related to establishing connection between pulmonary pressure and subtotal pressurisation by invoking inwards abdominal movements on controlled exhaled voiceless exercises (ssss-sound) Step 3 related to establishing dynamic control of subglottal pressure by performing fricative voice sounds (vvvf- and zzz-sounds) while contracting the abdominal wall inwards and thereby pressurising the pulmonary space leading to increased subglottal pressure on accents and extended pitch accents. | Behavioural | CVT Support optimisation |
| Dooming DiaphragmAlso: Osteopathic treatment of diaphragmOsteopathic treatment: Dooming Diaphragm. The inferior costal margin was contacted with the hands, allowing the thumbs to rest just below the ribcage anteriorly. Care was taken to avoid contact with the xiphoid process, as this could cause discomfort for the patient. The patient was instructed to breathe deeply, and as they exhaled, gentle pressure was applied superiorly and laterally with the thumbs, rolling them underneath the ribcage as far as was comfortable. This process was repeated for 3-5 breath cycles or until no tension was felt in the thumbs during exhalation. | Procedure or surgery | Osteopathy |
Primary outcome
Maximum Phonation Time
Time frame: Baseline
The total amount in seconds a sustained phonation can be maintained
Mean sound pressure level
Time frame: Baseline
Sound pressure level, SPL, to indicate vocal loudness.
Maximum and minimum fundamental frequency
Time frame: Baseline
The maximum and minimum fundamental frequency as an indicator of singing note pitch.
Fx SD
Time frame: Baseline
Fundamental Frequency Standard Deviation (Fx SD)
Qx
Time frame: Baseline
Average Contact Quotient (Qx)
Jitter
Time frame: Baseline
Amount (in %) of Jitter during cycle to cycle variation of vocal fold oscillations on a sustained vowel measured by electroglottography
Normalised Noise Energy
Time frame: Baseline
Normalised Noise Energy (NNE) of acoustic radiated output during phonation
Cepstral Peak Prominence
Time frame: Baseline
Cepstral Peak Prominence (CPP) of sustained phonation
Maximum Phonation Time
Time frame: Day 1
The total amount in seconds a sustained phonation can be maintained
Mean sound pressure level
Time frame: Day 1
Sound pressure level, SPL, to indicate vocal loudness.
Maximum and minimum fundamental frequency
Time frame: Day 1
The maximum and minimum fundamental frequency as an indicator of singing note pitch.
Fx SD
Time frame: Day 1
Fundamental Frequency Standard Deviation (Fx SD)
Qx
Time frame: Day 1
Average Contact Quotient (Qx)
Jitter
Time frame: Day 1
Amount (in %) of Jitter during cycle to cycle variation of vocal fold oscillations on a sustained vowel measured by electroglottography
Normalised Noise Energy
Time frame: Day 1
Normalised Noise Energy (NNE) of acoustic radiated output during phonation
Cepstral Peak Prominence
Time frame: Day 1
Cepstral Peak Prominence (CPP) of sustained phonation
Maximum Phonation Time - post intervention
Time frame: Day 1
The total amount in seconds a sustained phonation can be maintained
Mean sound pressure level - post intervention
Time frame: Day 1
Sound pressure level, SPL, to indicate vocal loudness.
Maximum and minimum fundamental frequency - post intervention
Time frame: Day 1
The maximum and minimum fundamental frequency as an indicator of singing note pitch.
Fx SD - post intervention
Time frame: Day 1
Fundamental Frequency Standard Deviation (Fx SD)
Qx - post intervention
Time frame: Day 1
Average Contact Quotient (Qx)
Jitter - post intervention
Time frame: Day 1
Amount (in %) of Jitter during cycle to cycle variation of vocal fold oscillations on a sustained vowel measured by electroglottography
Normalised Noise Energy - post intervention
Time frame: Day 1
Normalised Noise Energy (NNE) of acoustic radiated output during phonation
Cepstral Peak Prominence - post intervention
Time frame: Day 1
Cepstral Peak Prominence (CPP) of sustained phonation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No. To respect the anonymity of study participants, data will not be shared beyond reasonable request that ensures privacy and GDPR compliance.
Related trials for Singing
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
Active, not recruiting
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
AMD, Age-Related Macular Degeneration
Recruiting
The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
Stroke and Aphasia
Recruiting
Hybrid Group Singing
Coronary Artery Disease, Elderly
Recruiting
Addiction of Lung Volume Recruitment Technique in Lee Silverman Protocol for Voice Professionals
Voice Quality, Singing
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVT Support intervention and Dooming Diaphragm in people with Singing and Breathing Exercise, run by Complete Vocal Institute at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 6 Jun 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Baseline). The study lists 24 primary outcomes in all. 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 6 Jun 2025.