Dysfunctional BreathingSLPDBNCT04255446
Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing
An observational study of Dysfunctional Breathing, run by Pneumacare Ltd at 1 site in United Kingdom.
Trial summary
This is an observational, controlled, single-centre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. The core methodology involves capturing of data during a short period of measurement of breathing using SLP. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysfunctional Breathing
- What is being tested?
- Thora3DiTM
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2026to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO). • Cohort B: Any adult who is in good respiratory health will be considered for inclusion as a normal in the study.
Who may be able to join
- • Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO).
- Cohort B: Any adult who is in good respiratory health will be considered for inclusion as a normal in the study.
Who cannot join
- Subject unable to sit in an upright position for required period
- Subjects with significant co morbidities (assessed by the clinician at screening only):
- Chest wall or spinal deformity e.g. scoliosis OSA, Apnoea hypopnoea index > 30 (if known)
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants' ability to participate in the study
- BMI > 40
- Height > 194 cm
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study
- Inability to consent/comply with trial protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Controlled, Single Centre Study Validating the Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing
This is an observational, controlled, single-centre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. The core methodology involves capturing of data during a short period of measurement of breathing using SLP.
Read the detailed description
Cohort A: This study is a pilot study with four study visits (Screening, Baseline, week 13 and week 26) to generate data to characterise the tidal breathing patterns and parameters with Thora3Di™. Subjects will have a screening visit within 0 to 14 days prior to the first study visit. For each study visit, subjects will be seen in the clinical research facility and have two 5-minute SLP measurements (at rest and on exertion). The SLP measurement should be performed prior to standard lung function tests with minimal impact on clinical time and not change to hospital attendance. Also, each visit subjects will be asked to report concomitant medications and adverse events, and fill several questionnaires forms as outlined in the SOAs.
Cohort B: Healthy subjects will have only one visit for this study. After signing the informed consent form, subjects will undergo two 5-minutes SLP measurements (at rest and on exertion).
- Conditions
- Dysfunctional Breathing
- Being tested
- Thora3DiTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thora3DiTMDevice
Not international
| Study group | Role | What they receive |
|---|---|---|
| Dysfunctional Breathing | Patients with Dysfunctional breathing age between 16 to 75 will be included. Receives: Device: Thora3DiTM | |
| Healthy Volunteers | Healthy Volunteers without any respiratory problems age between 16 to 75 will be included. Receives: Device: Thora3DiTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estabilsih expected value and dispersion of Structured Light Phlethysmography in Dysfunctional breathing patients
Measure SLP parameters during the course of the treatment : Baseline, Week 13 and Week 26 at rest and at exertion
Measured: 26 weeks
Secondary outcomes (2)
Establish a relationship between Structured Light Phlethysmography parameters and patient report outcomes addressed.
Compare SLP parameters with patient outcome reports (Nijmegen and St George Respiratory Questionnaires and BPAT and BORG scores during the course of the treatment
Measured: 26 weeks
Establish different SLP parameters between patients with dysfunctional breathing and healthy subjects.
Compare the differences in SLP parameters between patients with dysfunctional breathing and healthy subjects
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startOct 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: Study terminated/withdrawn due to the prolonged timeline since initial ethical approval (without starting) and the number of significant changes to the management and structure of the study deemed appropriate for continuation due to the delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pneumacare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aashish Vyas, MD, Principal investigator, Royal Preston Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255446
- Sponsor's protocol ID
- PCL-SLPDB-2020
- Acronym
- SLPDB
- Status last verified
- Jun 2026
- First submitted
- 24 Jan 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Controlled, Single Centre Study Validating the Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing
- ClinicalTrials.gov ID
- NCT04255446
- Acronym / sponsor ID
- SLPDB / PCL-SLPDB-2020
- Conditions
- Dysfunctional Breathing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study terminated/withdrawn due to the prolonged timeline since initial ethical approval (without starting) and the number of significant changes to the management and structure of the study deemed appropriate for continuation due to the delays.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pneumacare LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational, controlled, single-centre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. The core methodology involves capturing of data during a short period of measurement of breathing using SLP.
Detailed description
Cohort A: This study is a pilot study with four study visits (Screening, Baseline, week 13 and week 26) to generate data to characterise the tidal breathing patterns and parameters with Thora3Di™. Subjects will have a screening visit within 0 to 14 days prior to the first study visit. For each study visit, subjects will be seen in the clinical research facility and have two 5-minute SLP measurements (at rest and on exertion). The SLP measurement should be performed prior to standard lung function tests with minimal impact on clinical time and not change to hospital attendance. Also, each visit subjects will be asked to report concomitant medications and adverse events, and fill several questionnaires forms as outlined in the SOAs.
Cohort B: Healthy subjects will have only one visit for this study. After signing the informed consent form, subjects will undergo two 5-minutes SLP measurements (at rest and on exertion).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysfunctional Breathing | – | Device: Thora3DiTMPatients with Dysfunctional breathing age between 16 to 75 will be included. |
| Healthy Volunteers | – | Device: Thora3DiTMHealthy Volunteers without any respiratory problems age between 16 to 75 will be included. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO). • Cohort B: Any adult who is in good respiratory health will be considered for inclusion as a normal in the study.
Key inclusion criteria (2 listed)
- • Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO).
Key exclusion criteria (8 listed)
- Subject unable to sit in an upright position for required period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thora3DiTMNot international | Device | Dysfunctional Breathing, Healthy Volunteers |
Primary outcome
Estabilsih expected value and dispersion of Structured Light Phlethysmography in Dysfunctional breathing patients
Time frame: 26 weeks
Measure SLP parameters during the course of the treatment : Baseline, Week 13 and Week 26 at rest and at exertion
2 secondary outcomes
Establish a relationship between Structured Light Phlethysmography parameters and patient report outcomes addressed.
Time frame: 26 weeks
Establish different SLP parameters between patients with dysfunctional breathing and healthy subjects.
Time frame: 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aashish Vyas, MD principal investigator
Royal Preston Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysfunctional Breathing, run by Pneumacare Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estabilsih expected value and dispersion of Structured Light Phlethysmography in Dysfunctional breathing patients (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.