Dysfunctional BreathingOptiMuscleNCT06103955
OptiMuscle - Improving Respiration by Optimising Muscle Function
A study testing Digital Breathing Biofeedback system in people with Dysfunctional Breathing and Breathing Pattern Disorder, run by University of Salford at 1 site in United Kingdom.
Trial summary
The primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunctional Breathing, Breathing Pattern Disorder
- What is being tested?
- Digital Breathing Biofeedback system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2024to 30 Jun 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to stand and walk independently
- History of breathing difficulties, such as breathlessness and difficult or laboured breathing for at least previous 6 months.
- Clinical diagnosis of dysfunctional breathing, sometimes referred to as breathing pattern disorder.
- If participants have co-existing respiratory problems, e.g. asthma, these should not be felt (in the opinion of the referring clinician) to be the cause of the current symptoms of breathlessness.
Who cannot join
- Inability to speak and understand English sufficient to read and understand the information sheet and sign the consent form.
- BMI >34
- Currently receiving active treatment for dysfunctional breathing
- Received treatment for acute lower respiratory tract infection or asthma exacerbation with last 4 weeks
- Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not asthma)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Salford
Manchester, Greater Manchester, M6 6PU
Stephen J Preece, PhD, +441612952273, s.preece@salford.ac.uk
About this study
Official title: Improving Outcomes in Dysfunctional Breathing Through the Optimization of Muscle Function (OptiMuscle)
The primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining.
Read the detailed description
Approximately 10% of people in the United Kindom exhibit some form of dysfunctional breathing. This term describes a range of conditions which are characterised by an impairment in the muscular control of breathing and which can result in breathlessness, hyperventilation and, in some cases, dizziness. Current clinical assessment techniques and treatments for dysfunctional breathing are low-tech. The investigators propose that patients would get more benefit from a system which uses biofeedback on muscle patterns to guide breathing re-education. The investigators have developed a new digital health system for the clinical management of dysfunctional breathing. The system uses an avatar to provide biofeedback to communicate abnormal muscle function in real-time, guiding patients through a process in which they gradually learn the correct muscular control of breathing. The proposed intervention seeks to understand if the addition of a digital breathing biofeedback system improves the outcomes of physiotherapy guided breathing retraining. Patients awaiting respiratory physiotherapy for dysfunctional breathing will be recruited to receive 4 sessions of breathing retraining with the assistance of the digital breathing biofeedback system. All patients will complete lung function tests and Quality of Life questionnaires pre- and post- treatment. Patients will also be offered an interview to understand their experiences of using the system.
- Being tested
- Digital Breathing Biofeedback system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breathing Biofeedback systemBehavioural
The biofeedback system provides information to the patient and physio about the muscle coordination of breathing.
| Study group | Role | What they receive |
|---|---|---|
| Digital Breathing Biofeedback system | Experimental | Patients will receive 4 physiotherapist-guided breathing retraining sessions with the digital breathing biofeedback system. Receives: Behavioral: Digital Breathing Biofeedback system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lung Function
Spirometry test of lung volume will be measured included tidal volume and forced expiratory volumes. (Larger volumes = better lung function)
Measured: Change from Baseline to 8 weeks
Secondary outcomes (4)
Change in Nijmegen Score
Used to capture the extent of hyperventilation. Score 0-64 (0=no hyperventilation, 64=maximum hyperventilation)
Measured: Change from Baseline to 8 weeks
Change in the Brief Illness Perception Questionnaire
Used ot evaluate cognitive and emotional representations of illness. Score 0-80 (0=no threatening perception of illness, 80=maximum threatening perception of illness)
Measured: Change from Baseline to 8 weeks
Change in Patient Health Questionnaire (PHQ-9)
Used to measure depression.Score 0-28 (0=no depression, 28=maximum depression)
Measured: Change from Baseline to 8 weeks
Change in the Generalised anxieity disorder (GAD-7)
Used to measure anxiety. Score 0-21 (no = no anxieity, 21=maximum anxiety)
Measured: Change from Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional BreathingStudies 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
- The primary aim is to carry out preliminary testing of the intervention and to use feedback from participants to make small changes to the intervention
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Preece, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103955
- Sponsor's protocol ID
- 2192
- Acronym
- OptiMuscle
- Status last verified
- Aug 2026
- First submitted
- 13 Oct 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators may make the clinical data available through a document which will be linked to the final published journal paper
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Dysfunctional Breathing Through the Optimization of Muscle Function (OptiMuscle)
- ClinicalTrials.gov ID
- NCT06103955
- Acronym / sponsor ID
- OptiMuscle / 2192
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Oct 2023 (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 primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining.
Detailed description
Approximately 10% of people in the United Kindom exhibit some form of dysfunctional breathing. This term describes a range of conditions which are characterised by an impairment in the muscular control of breathing and which can result in breathlessness, hyperventilation and, in some cases, dizziness. Current clinical assessment techniques and treatments for dysfunctional breathing are low-tech. The investigators propose that patients would get more benefit from a system which uses biofeedback on muscle patterns to guide breathing re-education. The investigators have developed a new digital health system for the clinical management of dysfunctional breathing. The system uses an avatar to provide biofeedback to communicate abnormal muscle function in real-time, guiding patients through a process in which they gradually learn the correct muscular control of breathing. The proposed intervention seeks to understand if the addition of a digital breathing biofeedback system improves the outcomes of physiotherapy guided breathing retraining. Patients awaiting respiratory physiotherapy for dysfunctional breathing will be recruited to receive 4 sessions of breathing retraining with the assistance of the digital breathing biofeedback system. All patients will complete lung function tests and Quality of Life questionnaires pre- and post- treatment. Patients will also be offered an interview to understand their experiences of using the system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The primary aim is to carry out preliminary testing of the intervention and to use feedback from participants to make small changes to the intervention
| Arm | Type | Receives |
|---|---|---|
| Digital Breathing Biofeedback system | Experimental | Behavioral: Digital Breathing Biofeedback systemPatients will receive 4 physiotherapist-guided breathing retraining sessions with the digital breathing biofeedback system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to stand and walk independently
- History of breathing difficulties, such as breathlessness and difficult or laboured breathing for at least previous 6 months.
- Clinical diagnosis of dysfunctional breathing, sometimes referred to as breathing pattern disorder.
- If participants have co-existing respiratory problems, e.g. asthma, these should not be felt (in the opinion of the referring clinician) to be the cause of the current symptoms of breathlessness.
Key exclusion criteria (5 listed)
- Inability to speak and understand English sufficient to read and understand the information sheet and sign the consent form.
- BMI >34
- Currently receiving active treatment for dysfunctional breathing
- Received treatment for acute lower respiratory tract infection or asthma exacerbation with last 4 weeks
- Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not asthma)
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 |
|---|---|---|
| Digital Breathing Biofeedback systemThe biofeedback system provides information to the patient and physio about the muscle coordination of breathing. | Behavioural | Digital Breathing Biofeedback system |
Primary outcome
Change in Lung Function
Time frame: Change from Baseline to 8 weeks
Spirometry test of lung volume will be measured included tidal volume and forced expiratory volumes. (Larger volumes = better lung function)
4 secondary outcomes
Change in Nijmegen Score
Time frame: Change from Baseline to 8 weeks
Change in the Brief Illness Perception Questionnaire
Time frame: Change from Baseline to 8 weeks
Change in Patient Health Questionnaire (PHQ-9)
Time frame: Change from Baseline to 8 weeks
Change in the Generalised anxieity disorder (GAD-7)
Time frame: Change from Baseline to 8 weeks
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 19 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The investigators may make the clinical data available through a document which will be linked to the final published journal paper
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Breathing Biofeedback system in people with Dysfunctional Breathing and Breathing Pattern Disorder, run by University of Salford at 1 site in United Kingdom.
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 4 inclusion and 5 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 19 Aug 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 Kingdom. 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 Stephen J Preece, PhD (+44 161 295 2273, s.preece@salford.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lung Function (time frame: Change from Baseline to 8 weeks). 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 19 Aug 2026.