Testing a breathing app for patients in the emergency room
| ISRCTN | ISRCTN66028175 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66028175 |
| IRAS number | 360871 |
| Secondary identifying numbers | F006-REG-AD/GB-25 |
- Submission date
- 26/08/2025
- Registration date
- 28/08/2025
- Last edited
- 24/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
This study is looking at a new device to measure aspects of breathing and heart rate. We want to test whether the new device works as well as traditional equipment. The new device is a smartphone application (app) which uses the video camera function. If the new device works as well as the standard methods, it could help doctors to better monitor and treat patients with breathing and heart diseases in the future.
Who can participate?
Males and females, aged 18 years and above, presenting at the Emergency Department at Addenbrooke's Hospital in Cambridge
What does the study involve?
You will be shown the new device and standard equipment. You will use the new app to measure your breathing over a 1-minute period. At the same time the nurse will count your number of breaths. This will be done three times. Next, the doctor or nurse will use the standard equipment (called a spirometer) to measure your breathing. This will be done three times. Then you will use the new device to measure your heart rate over a 1-minute period. At the same time the nurse will use standard equipment (called a pulse oximeter) to measure your heart rate. This will be done three times. Lastly, you will be given a short questionnaire with seven simple questions to say what you thought of using the new app.
What are the possible benefits and risks of participating?
There are no particular advantages of taking part in the study. Your participation is entirely voluntary, and there is no payment for taking part. Your participation may help to bring about a beneficial new way to monitor patients with disorders or diseases that affect their breathing, possibly preventing hospital admissions and bringing about earlier treatment if their disease flares up.
The app uses the smartphone camera to perform a simple non-invasive scan so there are no expected risks to you. If you have any technical problems or difficulties using the app, you may feel frustrated or anxious, but the study staff will always be on-hand to help. To help the app function correctly, we will use tape to secure a small marker to the back of each of your hands. There is a very low chance of skin reaction to the tape but if that did happen, a cold compress can be used, or calamine lotion to relieve any swelling or itchiness.
Where is the study run from?
Addenbrooke's Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2025 to March 2026
Who is funding the study?
electronRx Ltd (UK)
Who is the main contact?
Dr Bipin Patel (CEO of electronRx), admin@electronrx.com
Contact information
Principal investigator
Emergency Department
Addenbrooke's Hospital
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 596145 |
|---|---|
| adrianboyle@nhs.net |
Scientific
electronRx Ltd
Eagle Labs
28 Chesterton Road
Cambridge
CB4 3AZ
United Kingdom
| Phone | +44 (0)1223 944358 |
|---|---|
| admin@electronrx.com |
Public
Emergency Department
Addenbrooke's Hospital
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 596145 |
|---|---|
| adrianboyle@nhs.net |
Study information
| Study design | Single-centre single-visit study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | CLinical Evaluation of a mobile App-based Respiratory device in the Emergency Department setting (CLEAR-ED) |
| Study acronym | CLEAR-ED |
| Study objectives | The primary objectives of this study are to evaluate the agreement and usability of a new device, namely purpleDx smartphone application which uses video technology to measure patients’ peak expiratory flow, forced expiratory volume in one second, respiratory rate and heart rate. Results obtained using the purpleDx app will be compared to those measured using standard clinical reference methods during a single patient encounter in an Emergency Department setting. The secondary objectives are to demonstrate the safety of the purpleDx app and determine any subject subgroups or conditions of use of the new device that impair the quality or reliability of data. |
| Ethics approval(s) |
Submitted 08/08/2025, East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8096, +44 (0)207 104 8194, +44 (0)207 104 8269; cambsandherts.rec@hra.nhs.uk), ref: 25/EE/0187 |
| Health condition(s) or problem(s) studied | Respiratory disease |
| Intervention | There is no drug or other treatment involved in this study. It is a study to assess a new medical device compared to standard equipment. Once a participant has signed the Informed Consent form, they will be shown the new device and standard equipment. They will use the new device (purpleDx smartphone application) to measure their breathing over a 1-minute period. At the same time the nurse will count the number of breaths. This will be done three times. Next, the doctor or nurse will use the standard equipment (called a spirometer) to measure their breathing. This will be done three times. Then participants will use the new device to measure their heart rate over a 1-minute period. At the same time the nurse will use standard equipment (called a pulse oximeter) to measure their heart rate. This will be done three times. Lastly, participants will be given a short questionnaire with seven simple questions to say what they thought of using the new app. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | purpleDx smartphone application |
| Primary outcome measure | Peak expiratory flow measured by conventional and novel medical devices at a single visit |
| Secondary outcome measures | 1. Forced Expiratory Volume in one second (FEV1), heart rate and respiratory rate measured by conventional and novel medical devices at a single visit 2. The ease of using the novel medical device measured by a simple Likert-scale questionnaire at a single visit 3. The safety of the novel medical device assessed by evaluation of adverse events at a single visit 4. Patients and/or conditions not suitable for assessment by the novel medical device, determined by evaluation of missing, inaccurate and unreliable measurements produced by using the novel medical device at a single visit |
| Overall study start date | 08/08/2025 |
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 137 - 160 participants maximum |
| Key inclusion criteria | Current inclusion criteria as of 24/10/2025: 1. Sex at birth classified as male or female 2. 18 years of age and above, presenting to Addenbrooke's Hospital Emergency Department 3. Able to read and understand the participant information sheet in English 4. Capacity and ability to sign an informed consent form 5. With or without respiratory or cardiorespiratory symptom/s Previous inclusion criteria: 1. Male or female 2. Aged 18 years and above, presenting to Addenbrooke's Hospital Emergency Department 3. Able to read/understand/write in English 4. With or without a medical diagnosis of respiratory or cardiopulmonary condition/s |
| Key exclusion criteria | Current exclusion criteria as of 24/10/2025: 1. Unable to sit up i.e. cannot lie completely flat (supine) 2. Known pregnancy in women of child-bearing potential 3. Unable to comply with the requirements of the investigation in any way 4. Prisoners or young offenders Previous exclusion criteria: 1. Unable to sit up 2. Determined not to have capacity to provide consent to participate in the study 3. Known pregnancy in women of childbearing potential 4. Unable to comply with the requirements of the investigation in any way 4. Prisoners |
| Date of first enrolment | 27/11/2025 |
| Date of final enrolment | 27/02/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Emergency Department
Box 87
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Industry
Eagle Labs
28 Chesterton Road
Cambridge
CB4 3AZ
England
United Kingdom
| Phone | +44 (0)1223 944358 |
|---|---|
| admin@electronrx.com | |
| Website | https://electronrx.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 14/10/2025 | 24/10/2025 | No | No |
Additional files
Editorial Notes
24/10/2025: The following changes were made to the study record:
1. The date of first enrolment was changed from 02/10/2025 to 27/11/2025.
2. The date of final enrolment was changed from 31/12/2025 to 27/02/2026.
3. The completion date was changed from 31/12/2025 to 31/03/2026.
4. The intention to publish date was changed from 31/12/2026 to 31/03/2027.
5. The target number of participants was changed from 125 - 150 participants maximum to 137 - 160 participants maximum.
6. Protocol uploaded.
28/08/2025: Study's existence confirmed by East of England - Cambridgeshire and Hertfordshire Research Ethics Committee.
