Dysfunctional Breathing: Characterisation and Assessment
NCT03043469 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 141
Last updated 2020-07-08
Summary
Dysfunctional breathing (DB) is a respiratory condition characterised by an abnormal breathing pattern, among other complaints, that can occur either in the absence of other pathophysiology (primary DB), e.g. anxiety-related factors, or secondary to cardiopulmonary disease (secondary DB), e.g. asthma. As a consequence, patients may experience breathlessness and present with periods of increased ventilation or erratic breathing, interspersed with episodes of breath holding or deep sighs. In addition to respiratory symptoms, DB also generates non- respiratory symptoms (e.g. dizziness and increased heart rate). It is estimated 1 in 10 people in the United Kingdom (UK) have DB. However, DB remains poorly understood, with no standardised approach to diagnosis and assessment.
The purposes of this study are:
Study 1) To identify physiological, functional and psychological characteristics of participants with DB compared to healthy participants.
Firstly, symptoms, lung function, respiratory gas analysis, exercise capacity, respiratory muscle function, respiratory motion, level of physical activity, quality of life and anxiety \& depression scores will be assessed in 20 participants with primary DB, 20 with secondary DB and compared to 20 healthy participants.
Study 2) To develop an assessment tool based on physiological, functional or psychological variables found to be different between any of the 3 groups in Study 1.
In order to do that, 54 people with DB (between primary and secondary) and 27 people presenting with breathlessness secondary to restrictive lung disease will be assessed. Analysis of these data will determine whether these variables can be used as a diagnostic tool capable of distinguishing DB from restrictive lung diseases characterised by breathlessness.
The recruitment period will be 1-2 years, with an individual participation of 9 days; 1-day on site testing, plus 7-day home activity monitoring, and 1 day to return the activity monitor (which will happen whenever the participant needs to return to the site).
Conditions
- Respiration Disorder
- Hyperventilation Syndrome
- Breathlessness
- Breath Shortness
Interventions
- OTHER
-
Short-form survey instrument
Questionnaire with questions about quality of life. Takes about 5 minutes to be completed.
- OTHER
-
Demographic data
height, weight, age, gender, list of comorbidities, health history, level of physical activity, medicines in use. Takes about 10 minutes to be completed.
- OTHER
-
Hospital Anxiety and Depression Scale
Questionnaire with questions about anxiety and depression. Takes about 5 minutes to be completed.
- OTHER
-
Nijmegen questionnaire
Answering questions about symptoms related to breathing. Takes about 5 minutes to be completed.
- OTHER
-
The Self-evaluation of breathing questionnaire
Answering questions about self-evaluation of breathing. Takes about 5 minutes to be completed
- OTHER
-
six-minute exercise test
Cycling against certain load in a bicycle for 6 minutes. Takes about 16 minutes to be completed together with indirect calorimetry, oxygen saturation monitoring, heart rate variability analysis and continuous monitoring of arterial blood pressure).
- OTHER
-
Indirect calorimetry
Breathing through a mask that measures levels of oxygen, carbon dioxide, breathing frequency and others (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.
- OTHER
-
Oxygen saturation monitoring
The measurement of the amount of oxygen which is attached to haemoglobin molecules (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.
- OTHER
-
Heart rate variability analysis
Measurement of the variation in the beat-to-beat interval (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.
- OTHER
-
Continuous measurement of arterial blood pressure
Measurement of blood pressure based on the peripheral pulse using a finger cuff (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.
- DIAGNOSTIC_TEST
-
Lung function test
Breathing through a mouth-piece in many different ways in order to measure the function of the lungs (non-invasively).
- OTHER
-
Respiratory muscle function
Breathing through a mouth-piece in many different ways in order to measure the function of the respiratory muscles (non-invasively).
- OTHER
-
Manual assessment of respiratory motion
Measure of the movements of the thorax while the participant is breathing (non-invasively).
- OTHER
-
Breath-hold test
Holding the breath a few times for as long as possible.
- OTHER
-
Physical Activity monitoring
Wearing a light-weight activity monitor to be wore on the hip for 7 consecutive days during, at least, 8 hours per day.
- OTHER
-
Asthma Control Questionnaire
Only for asthmatics: answering questions about the control the participant has over this respiratory condition/symptoms.
Sponsors & Collaborators
-
University of Sao Paulo
collaborator OTHER -
Brunel University
lead OTHER
Principal Investigators
-
Panagiota Smyrni, Dr · Brunel University London
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-08-08
- Primary Completion
- 2021-04-30
- Completion
- 2021-05-30
Countries
- United Kingdom
Study Locations
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