ClinicalTrials.gg
RecruitingNCT06103955OptiMuscleUpdated Aug 19, 2026

OptiMuscle - Improving Respiration by Optimising Muscle Function

An interventional study of Digital Breathing Biofeedback system in Dysfunctional Breathing and Breathing Pattern Disorder, sponsored by University of Salford. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by University of Salford · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dysfunctional Breathing
  • Breathing Pattern Disorder
03

In context

Lead sponsor

University of Salford is the lead sponsor of 27 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Inability to speak and understand English sufficient to read and understand the information sheet and sign the consent form.
  • >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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Digital Breathing Biofeedback system

    Patients will receive 4 physiotherapist-guided breathing retraining sessions with the digital breathing biofeedback system.

    Behavioral: Digital Breathing Biofeedback system

Interventions

  • BehavioralDigital Breathing Biofeedback system

    The biofeedback system provides information to the patient and physio about the muscle coordination of breathing.

06

What researchers measure

Primary outcomes

  1. Change in Lung Function

    Spirometry test of lung volume will be measured included tidal volume and forced expiratory volumes. (Larger volumes = better lung function)

    Time frame: Change from Baseline to 8 weeks

Secondary outcomes

  1. Change in Nijmegen Score

    Used to capture the extent of hyperventilation. Score 0-64 (0=no hyperventilation, 64=maximum hyperventilation)

    Time frame: Change from Baseline to 8 weeks

  2. 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)

    Time frame: Change from Baseline to 8 weeks

  3. Change in Patient Health Questionnaire (PHQ-9)

    Used to measure depression.Score 0-28 (0=no depression, 28=maximum depression)

    Time frame: Change from Baseline to 8 weeks

  4. Change in the Generalised anxieity disorder (GAD-7)

    Used to measure anxiety. Score 0-21 (no = no anxieity, 21=maximum anxiety)

    Time frame: Change from Baseline to 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Related links

Individual participant data

Plan to share: Undecided — The investigators may make the clinical data available through a document which will be linked to the final published journal paper

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06103955
Lead sponsor
University of Salford
Responsible party
Stephen Preece (Professor of Biomechanics and Rehabilitation, University of Salford) — Principal investigator
First posted
Oct 27, 2023
Start date
Mar 1, 2024
Primary completion
Mar 31, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Stephen J Preece, PhD
Contact
s.preece@salford.ac.uk
+44 161 295 2273
Adam M Handley, MSc
Contact
a.m.handley@salford.ac.uk
+44 161 295 6758

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion