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Recruiting

NCT Number: NCT06507228

North West London Pebble Pathway: Automated OSA Diagnosis

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.

Recruiting

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charing Cross Hospital

London, W12 0HS, United Kingdom

Location status: Recruiting

Location contact

Patrik Bachtiger

CONTACT

[email protected]

07814396222

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • OSA testing referral from primary care

Exclusion criteria

  • Unable to follow test instructions

Treatment and study plan

NWL PEBBLE STT

Diagnostic Test

At home testing for OSA with AcuPebble.

Primary outcomes

  1. Time to diagnosis

    Time frame: 12 months

    Time to diagnosis vs. historical control group

Secondary outcomes

  1. Cost saving per test

    Time frame: 12 months

    Cost saving per test in pounds sterling compared to control group

  2. Test completion rate

    Time frame: 12 months

    Completion rate as proxy for health equity

  3. Financial saving to patients from cutting journeys associated with appointments

    Time frame: 12 months

    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.

  4. Sustainability impacts by carbon footprint reduction

    Time frame: 12 months

    CO2 footprint from averted technologies (reduced plastic waste) and reduced patient journeys (CO2 footprint reduction from miles travelled, calculated using Echochain carbon footprint calculator).

  5. Time saving to patients from cutting journeys associated with appointments

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrik Bachtiger

CONTACT

[email protected]

07814396222

Sponsors and collaborators

Lead sponsor

Patrik Bachtiger

Other

Registry information

Acronym: PEBBLE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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