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Testing a breathing app for patients in the emergency room

CLinical Evaluation of a mobile App-based Respiratory device in the Emergency Department setting (CLEAR-ED)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN66028175
Enrollment
137
Registered
2025-08-28
Start date
2025-11-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory disease Respiratory

Interventions

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

Sponsors

electronRx Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Peak expiratory flow measured by conventional and novel medical devices at a single visit

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactAdrian Boyle
adrianboyle@nhs.net+44 (0)1223 596145

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026