None listed
Conditions
Brief summary
The purpose of this study is to test if a medical device called a SpiroNose® can be used to diagnose health conditions that cause respiratory symptoms, lung imaging abnormalities and sleep disorders. Who is it for? You may be eligible for this study if you are an adult who is either: 1. attending clinic for assessment of your respiratory symptoms or sleep or lung conditions, or 2. in the community and do not currently experience any respiratory symptoms or have lung abnormalities or any sleep conditions Study details Participants will be asked to perform a breath test on a device called a SpiroNose® . This breath test involves gentle breathing into the mouthpiece of the SpiroNose® and takes about 1 minute. Participants will also be asked to complete a few questionnaires immediately after the breath test. One questionnaire asks the participant what they thought about the SpiroNose® breath test; other questionnaires are used to collect clinical information such as the diagnosis of their current condition, if their condition has been diagnosed, and other health issues they may have. All participants will be followed up with a telephone call 2 months later to check if health status has changed, if medications have changed or if they have had more medical tests. The study coordinator will check their medical records for the final diagnosis up to 24 months after the breath test. Participants attending the respiratory clinic for assessment or management of lung cancer may be invited by their treating physician to perform a second SpiroNose® breath test after surgery or treatment as part of their clinical care. It is hoped that this research study will help determine if the SpiroNose® device can be used to identify participants with medical conditions such as asthma, chronic obstructive pulmonary disease, lung cancer, bronchiectasis, interstitial lung abnormalities, cardiac failure, obstructive sleep apnoea and narcolepsy.
Interventions
The intervention is an electronic nose called SpiroNose®. It is a breath analyser that participants breathe into for a few seconds to enable it to analyse patterns of chemicals called volatile organic compounds, which may differ between people with different medical conditions.
The SpiroNose® breath test is administered by an experienced study coordinator during a participant’s routine respiratory or sleep clinic visit. Participants breathe normally into the mouthpiece 5 times before filling t
The intervention is an electronic nose called SpiroNose®. It is a breath analyser that participants breathe into for a few seconds to enable it to analyse patterns of chemicals called volatile organic compounds, which may differ between people with different medical conditions. The SpiroNose® breath test is administered by an experienced study coordinator during a participant’s routine respiratory or sleep clinic visit. Participants breathe normally into the mouthpiece 5 times before filling the lungs, holding this for 5 seconds, then slowly breathing all the air out, followed finally by a deep breath before coming off the mouthpiece. Participants complete a short questionnaire after the breath test to determine how acceptable they found the SpiroNose® breath test (ie how easy or difficult it was to perform). They also complete questionnaires about their health, including medical diagnoses, medications and symptoms. All questionnaires are de-identified. Two months after the study visit, the study coordinator will contact participants by telephone to ask whether they have received a diagnosis, had any changes to their treatment or medications, and whether they have undergone any additional investigations. Relevant information may also be collected from participants' medical records from the time of the breath test up to 24 months later. Participants attending the respiratory clinic for assessment or management of lung cancer may be invited by their treating physician to perform a second SpiroNose® breath test after surgery or treatment as part of their clinical care.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients attending routine respiratory, sleep or lung assessment are potentially eligible if aged 18 years or over, are willing to provide written informed consent AND have any chronic respiratory or sleep symptoms (cough, wheeze, shortness of breath, chest tightness, haemoptysis) or diagnoses that may cause or contribute to respiratory symptoms (including but not limited to asthma, COPD, lung cancer, interstitial lung abnormalities, cardiac failure, obstructive sleep apnoea or narcolepsy) and/or have abnormalities on lung imaging. Adults in the community may be eligible as controls if they are aged 18 years or over, provide written informed consent, and do not have any of the symptoms or conditions listed above.
Exclusion criteria
Potential participants will be excluded from enrolment in the study if they have: •Any condition that interferes with their ability to understand the study requirements. •Any condition with a life expectancy of less than 6 months
Outcome results
None listed