NCT07007845

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

4 days

First QC Date

April 28, 2025

Last Update Submit

June 3, 2025

Conditions

Keywords

Diaphragm functionSinging techniqueSupportOsteopathy

Outcome Measures

Primary Outcomes (24)

  • Maximum Phonation Time

    The total amount in seconds a sustained phonation can be maintained

    Baseline

  • Mean sound pressure level

    Sound pressure level, SPL, to indicate vocal loudness.

    Baseline

  • Maximum and minimum fundamental frequency

    The maximum and minimum fundamental frequency as an indicator of singing note pitch.

    Baseline

  • Fx SD

    Fundamental Frequency Standard Deviation (Fx SD)

    Baseline

  • Qx

    Average Contact Quotient (Qx)

    Baseline

  • Jitter

    Amount (in %) of Jitter during cycle to cycle variation of vocal fold oscillations on a sustained vowel measured by electroglottography

    Baseline

  • Normalised Noise Energy

    Normalised Noise Energy (NNE) of acoustic radiated output during phonation

    Baseline

  • Cepstral Peak Prominence

    Cepstral Peak Prominence (CPP) of sustained phonation

    Baseline

  • Maximum Phonation Time

    The total amount in seconds a sustained phonation can be maintained

    Day 1

  • Mean sound pressure level

    Sound pressure level, SPL, to indicate vocal loudness.

    Day 1

  • Maximum and minimum fundamental frequency

    The maximum and minimum fundamental frequency as an indicator of singing note pitch.

    Day 1

  • Fx SD

    Fundamental Frequency Standard Deviation (Fx SD)

    Day 1

  • Qx

    Average Contact Quotient (Qx)

    Day 1

  • Jitter

    Amount (in %) of Jitter during cycle to cycle variation of vocal fold oscillations on a sustained vowel measured by electroglottography

    Day 1

  • Normalised Noise Energy

    Normalised Noise Energy (NNE) of acoustic radiated output during phonation

    Day 1

  • Cepstral Peak Prominence

    Cepstral Peak Prominence (CPP) of sustained phonation

    Day 1

  • Maximum Phonation Time - post intervention

    The total amount in seconds a sustained phonation can be maintained

    Day 1

  • Mean sound pressure level - post intervention

    Sound pressure level, SPL, to indicate vocal loudness.

    Day 1

  • Maximum and minimum fundamental frequency - post intervention

    The maximum and minimum fundamental frequency as an indicator of singing note pitch.

    Day 1

  • Fx SD - post intervention

    Fundamental Frequency Standard Deviation (Fx SD)

    Day 1

  • Qx - post intervention

    Average Contact Quotient (Qx)

    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

    Day 1

  • Normalised Noise Energy - post intervention

    Normalised Noise Energy (NNE) of acoustic radiated output during phonation

    Day 1

  • Cepstral Peak Prominence - post intervention

    Cepstral Peak Prominence (CPP) of sustained phonation

    Day 1

Study Arms (2)

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.

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.

Procedure: Dooming Diaphragm

Interventions

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.

Also known as: CVT Support
CVT Support optimisation

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.

Also known as: Osteopathic treatment of diaphragm
Osteopathy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • General health, no known vocal pathology or ongoing respiratory infection
  • No ongoing reflux symptoms
  • Amateur singer

You may not qualify if:

  • No prior osteopathic treatment related to voice
  • No prior CVT Support Training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complete Vocal Institute

Copenhagen, 1208, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

June 6, 2025

Study Start

March 3, 2025

Primary Completion

March 7, 2025

Study Completion

April 28, 2025

Last Updated

June 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

To respect the anonymity of study participants, data will not be shared beyond reasonable request that ensures privacy and GDPR compliance.

Locations