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NCT Number: NCT06103955

OptiMuscle - Improving Respiration by Optimising Muscle Function

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Salford

Manchester, Greater Manchester, M6 6PU, United Kingdom

Location status: Recruiting

Location contact

Stephen J Preece, PhD

CONTACT

[email protected]

+441612952273

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Digital Breathing Biofeedback system

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in Nijmegen Score

    Time frame: Change from Baseline to 8 weeks

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

  2. Change in the Brief Illness Perception Questionnaire

    Time frame: Change from Baseline to 8 weeks

    Used ot evaluate cognitive and emotional representations of illness. Score 0-80 (0=no threatening perception of illness, 80=maximum threatening perception of illness)

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

    Time frame: Change from Baseline to 8 weeks

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

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

    Time frame: Change from Baseline to 8 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Adam M Handley, MSc

CONTACT

[email protected]

+44 161 295 6758

Stephen J Preece, PhD

CONTACT

[email protected]

+44 161 295 2273

Sponsors and collaborators

Lead sponsor

University of Salford

Other

Registry information

Official study title

Improving Outcomes in Dysfunctional Breathing Through the Optimization of Muscle Function (OptiMuscle)

Acronym: OptiMuscle

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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