North West London Pebble Pathway: Automated OSA Diagnosis

NCT ID: NCT06507228

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-07
• Study Completion Date: 2025-12-01

Brief 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. 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).

Conditions

Obstructive Sleep Apnea; Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NWL PEBBLE STT patients

Real-world clinical care arm investigating novel pathway

Group Type: OTHER

NWL PEBBLE STT

Intervention Type: DIAGNOSTIC_TEST

At home testing for OSA with AcuPebble.

Interventions

NWL PEBBLE STT

At home testing for OSA with AcuPebble.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• OSA testing referral from primary care

Exclusion Criteria

• Unable to follow test instructions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patrik Bachtiger

OTHER

Sponsor Role: lead

Responsible Party

Patrik Bachtiger

NIHR Academic Clinical Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Charing Cross Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Patrik Bachtiger

Role: CONTACT

p.bachtiger@imperial.ac.uk

07814396222

Facility Contacts

Patrik Bachtiger

Role: primary

p.bachtiger@imperial.ac.uk

07814396222

References

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.

Reference Type: BACKGROUND

PMID: 34933855 (View on PubMed)

Other Identifiers

PA8366

Identifier Type: -

Identifier Source: org_study_id