OptiMuscle - Improving Respiration by Optimising Muscle Function

NCT ID: NCT06103955

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysfunctional Breathing Breathing Pattern Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Digital Breathing Biofeedback system

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

Group Type EXPERIMENTAL

Digital Breathing Biofeedback system

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Breathing Biofeedback system

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Salford

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stephen Preece

Professor of Biomechanics and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Salford

Manchester, Greater Manchester, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stephen J Preece, PhD

Role: CONTACT

+44 161 295 2273

Adam M Handley, MSc

Role: CONTACT

+44 161 295 6758

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stephen J Preece, PhD

Role: primary

+441612952273

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2192

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.