University of Salford
Manchester, Greater Manchester, M6 6PU, United Kingdom
Location status: Recruiting
NCT Number: NCT06103955
The primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Manchester, Greater Manchester, M6 6PU, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The biofeedback system provides information to the patient and physio about the muscle coordination of breathing.
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)
Time frame: Change from Baseline to 8 weeks
Used to capture the extent of hyperventilation. Score 0-64 (0=no hyperventilation, 64=maximum hyperventilation)
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)
Time frame: Change from Baseline to 8 weeks
Used to measure depression.Score 0-28 (0=no depression, 28=maximum depression)
Time frame: Change from Baseline to 8 weeks
Used to measure anxiety. Score 0-21 (no = no anxieity, 21=maximum anxiety)
Contact information is provided by the study sponsor or research team.
Adam M Handley, MSc
CONTACT
Stephen J Preece, PhD
CONTACT
University of Salford
Other
Improving Outcomes in Dysfunctional Breathing Through the Optimization of Muscle Function (OptiMuscle)
Acronym: OptiMuscle
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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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