Obstructive Sleep ApneaPEBBLENCT06507228
North West London Pebble Pathway: Automated OSA Diagnosis
A study testing NWL PEBBLE STT in people with Obstructive Sleep Apnea and Sleep Apnea, run by Patrik Bachtiger at 1 site in United Kingdom.
Trial summary
Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test. Early diagnosis enables optimal treatment, mitigating risks including heart failure, lung disease, and stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Apnea
- What is being tested?
- NWL PEBBLE STT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSA testing referral from primary care
Who cannot join
- Unable to follow test instructions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Charing Cross Hospital
London, W12 0HS
Patrik Bachtiger, 07814396222, p.bachtiger@imperial.ac.uk
About this study
Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test. Early diagnosis enables optimal treatment, mitigating risks including heart failure, lung disease, and stroke. Current diagnostic approaches are expensive (£391), time-consuming (>1-hour interpretation), uncomfortable (cables/tubes/wires), and inequitable (multiple hospital visits). Overcoming all these limitations, we have designed and will investigate a straigh-to-test automated diagnostic pathway for OSA. This will use the AcuPebble, a miniature wearable acoustic sensor and the first regulated technology for automated, at-home diagnosis. The test is cheap (< £100); time-saving; endorsed by patients, and accessible (posted directly to patients). This project will measure the impact of a potentially transformative, innovative, and scalable diagnostic pathway using AcuPebble technology.
Read the detailed description
The investigators are conducting a prospective implementation and health economic study of a novel straight-to-test (STT) clinical diagnostic pathway for OSA, using a novel, regulatory-approved wearable medical device for automated diagnosis of OSA in the home setting (AcuPebble SA100). The setting is real-world direct clinical care, with participation from three NHS sleep medicine centres servicing the North West London region.
Inclusion criteria is primary care referrals for OSA investigation were triaged onto the pathway based on predetermined criteria, compared to a historical cohort of patients undergoing STT using cardiorespiratory polygraphy (CR-PG) technology serving as a control group. The primary outcome is time-to-diagnosis. Secondary outcomes include NHS cost-saving per patient; surrogates for health equity (e.g. test completion rates, time/cost of journeys saved); and carbon footprint reduction from averted patient journeys (sustainability).
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea
- Being tested
- NWL PEBBLE STT
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NWL PEBBLE STTDiagnostic test
At home testing for OSA with AcuPebble.
| Study group | Role | What they receive |
|---|---|---|
| NWL PEBBLE STT patients | Other | Real-world clinical care arm investigating novel pathway Receives: Diagnostic Test: NWL PEBBLE STT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis
Time to diagnosis vs. historical control group
Measured: 12 months
Secondary outcomes (5)
Cost saving per test
Cost saving per test in pounds sterling compared to control group
Measured: 12 months
Test completion rate
Completion rate as proxy for health equity
Measured: 12 months
Financial saving to patients from cutting journeys associated with appointments
Cost saved from averted journeys by per patient cost of public transport and time taken to travel; informed by mapping journey per patient post-code to sleep study centre.
Measured: 12 months
Sustainability impacts by carbon footprint reduction
CO2 footprint from averted technologies (reduced plastic waste) and reduced patient journeys (CO2 footprint reduction from miles travelled, calculated using Echochain carbon footprint calculator).
Measured: 12 months
Time saving to patients from cutting journeys associated with appointments
Time saved from averted journeys by per patient cost of public transport and time taken to travel; informed by mapping journey per patient post-code to sleep study centre.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start7 Jul 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Propspective real world implementation and health economic study; historical control group for comparison
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrik Bachtiger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrik Bachtiger, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507228
- Sponsor's protocol ID
- PA8366
- Acronym
- PEBBLE
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharable upon reasonable request.
Publications
Devani N, Pramono RXA, Imtiaz SA, Bowyer S, Rodriguez-Villegas E, Mandal S. Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open. 2021 Dec 21;11(12):e046803. doi: 10.1136/bmjopen-2020-046803.
PubMed 34933855
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- North West London Pebble Pathway: Automated OSA Diagnosis
- ClinicalTrials.gov ID
- NCT06507228
- Acronym / sponsor ID
- PEBBLE / PA8366
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Patrik BachtigerUniversity, hospital or other
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Jul 2024 (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.
Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test. Early diagnosis enables optimal treatment, mitigating risks including heart failure, lung disease, and stroke. Current diagnostic approaches are expensive (£391), time-consuming (>1-hour interpretation), uncomfortable (cables/tubes/wires), and inequitable (multiple hospital visits). Overcoming all these limitations, we have designed and will investigate a straigh-to-test automated diagnostic pathway for OSA. This will use the AcuPebble, a miniature wearable acoustic sensor and the first regulated technology for automated, at-home diagnosis. The test is cheap (< £100); time-saving; endorsed by patients, and accessible (posted directly to patients). This project will measure the impact of a potentially transformative, innovative, and scalable diagnostic pathway using AcuPebble technology.
Detailed description
The investigators are conducting a prospective implementation and health economic study of a novel straight-to-test (STT) clinical diagnostic pathway for OSA, using a novel, regulatory-approved wearable medical device for automated diagnosis of OSA in the home setting (AcuPebble SA100). The setting is real-world direct clinical care, with participation from three NHS sleep medicine centres servicing the North West London region.
Inclusion criteria is primary care referrals for OSA investigation were triaged onto the pathway based on predetermined criteria, compared to a historical cohort of patients undergoing STT using cardiorespiratory polygraphy (CR-PG) technology serving as a control group. The primary outcome is time-to-diagnosis. Secondary outcomes include NHS cost-saving per patient; surrogates for health equity (e.g. test completion rates, time/cost of journeys saved); and carbon footprint reduction from averted patient journeys (sustainability).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Propspective real world implementation and health economic study; historical control group for comparison
| Arm | Type | Receives |
|---|---|---|
| NWL PEBBLE STT patients | Other | Diagnostic Test: NWL PEBBLE STTReal-world clinical care arm investigating novel pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OSA testing referral from primary care
Key exclusion criteria (1 listed)
- Unable to follow test instructions
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 |
|---|---|---|
| NWL PEBBLE STTAt home testing for OSA with AcuPebble. | Diagnostic test | NWL PEBBLE STT patients |
Primary outcome
Time to diagnosis
Time frame: 12 months
Time to diagnosis vs. historical control group
5 secondary outcomes
Cost saving per test
Time frame: 12 months
Test completion rate
Time frame: 12 months
Financial saving to patients from cutting journeys associated with appointments
Time frame: 12 months
Sustainability impacts by carbon footprint reduction
Time frame: 12 months
Time saving to patients from cutting journeys associated with appointments
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Background: PubMed 34933855Devani N, Pramono RXA, Imtiaz SA, Bowyer S, Rodriguez-Villegas E, Mandal S. Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open. 2021 Dec 21;11(12):e046803. doi: 10.1136/bmjopen-2020-046803.
- Individual participant dataSharing planned: No. Sharable upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NWL PEBBLE STT in people with Obstructive Sleep Apnea and Sleep Apnea, run by Patrik Bachtiger 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrik Bachtiger (07814396222, p.bachtiger@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to diagnosis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06507228, which also lists 1 linked publication.
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 18 Jul 2024.