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A randomised controlled trial to identify Obstructive Sleep Apnoea (OSA) in primary care

Case finding of obstructive sleep apnoea in primary care using a novel device: a randomised controlled trial (FOUND)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16982033
Enrollment
1426
Registered
2023-07-03
Start date
2023-07-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Case finding of obstructive sleep apnoea in primary care Respiratory

Interventions

Current interventions as of 26/06/2024: WP1: Feasibility. The study will include an internal feasibility phase to assess the fidelity of the delivery of the new device in General Practice and its ac

Sponsors

University of Warwick
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 50 - 70 years 2. BMI>=30 kg/m² as of GP records in the last 3 years 3. Diabetes (type 1 or 2) OR hypertension (office BP > 140/90 mmHg or on treatment) OR both diabetes and hypertension

Exclusion criteria

Exclusion criteria: 1. Patients with known OSA 2. Patients with known moderate-to-severe COPD 3. Those deemed unable to take part by their GP (e.g. terminally ill) 4. Patients with known allergy to acrylate

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 26/06/2024: To compare the detection rate of moderate-to-severe OSA in high-risk groups within General Practice between the intervention and usual care groups between randomisation and 6 months follow-up general practice notes review. _____ Previous primary outcome measure: Number of participants diagnosed with moderate-to-severe OSA, defined as an AHI reading of 15 to 30 (moderate) or >30 (severe) episodes per hour from the AcuPebble report (intervention group) or GP notes review at six months (control group).

Secondary

MeasureTime frame
Current secondary outcome measures as of 26/06/2024: 1. To compare the duration of time to diagnose moderate-to-severe OSA between the intervention and usual care groups between randomisation and diagnosis of moderate-to-severe OSA. Baseline, 6 months general practice notes review. 2. To compare the duration of time to diagnose individuals with evidence of EDS/OSAS between the intervention and usual care groups between randomisation and date treatment starts. Baseline, 6 months general practice notes review. 3. To compare the duration of time to test for OSA/OSAS in high-risk groups within general practice between the intervention and usual care groups between randomisation to completion of testing for OSA/OSAS. 4. To compare the duration of time to start treatment between the intervention and usual care groups between randomisation to treatment start. 5. To compare the incremental cost-effectiveness of the intervention over usual care from both the NHS and societal perspectives using Health Care resources EQ-5D-5L and CSRI at baseline and 6 months general practice notes review. 6. To compare the detection rate of OSA (mild, moderate or severe), in high-risk groups within general practice between intervention and usual care groups. 7. To compare the detection rate of OSAS in high-risk groups within general practice between intervention and usual care. Feasibility: To assess fidelity of the delivery of the new device in General Practice. Looking at: 1. Acceptability to patients 2. Acceptability to primary care team 3. Number of practices recruited 4. Number of participants recruited 5. Data completion at baseline, 6 months, GP notes review _____ Previous secondary outcome measures: 1. Time to diagnosis of OSA (for those with a positive diagnosis) from OSA questionnaire and GP notes review at six months. 2. Time to start treatment (for those with a positive diagnosis) from OSA questionnaire and GP notes review at six months. 3. Health-related Quality of Life is

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026