The Sunrise OSA Trial

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Sunrise; Device: Polygraphy

• Registration Number: NCT05204004
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

A prospective, randomised, blinded pilot study comparing the Sunrise solution and overnight polygraphy for the diagnosis of OSA in adult patients. Patients under investigation for OSA will use both devices simultaneously for a single overnight sleep study. They will be randomised to receive their treatment decision based on either the Sunrise solution or polygraphy. A retrospective check of their diagnosis will be done.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-21
• Study Start: 2021-08-21
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Status Verified: 2023-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged ≥18
2. Ability and willingness to provide informed consent
3. Patient referred for suspected OSA
4. BMI >28 kg/m2
5. Epworth Sleepiness Score >12
6. Reported snoring (criterion may be ignored if patient sleeps alone)
7. Patient able to use a smartphone application and having an internet connection at home

Exclusion Criteria

1. Patient already treated for OSA
2. Patient has PSV or HGV driving license
3. Unstable cardiac disease
4. Supplemental oxygen
5. Known secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome
6. Concerns about sleepy driving or any other potentially dangerous symptom from physician or urgent referral from GP when patient has been told to stop driving
7. Pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
8. Patient whose beard is too thick to wear the Sunrise device, and who does not wish to shave
9. Patient with acrylic or painted fingernails, who does not wish to remove acrylic or paint

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunrise	Sunrise	Participants under investigation for OSA will use both devices (Sunrise solution and overnight polygraphy) simultaneously for a single overnight sleep study. Participants randomised to the 'Sunrise' arm will receive their treatment decision based on the Sunrise solution.
Polygraphy	Polygraphy	Participants under investigation for OSA will use both devices (Sunrise solution and overnight polygraphy) simultaneously for a single overnight sleep study. Participants randomised to the 'polygraphy' arm will receive their treatment decision based on the polygraphy.

Primary Outcome Measures

Name	Time	Method
Time to treatment decision	From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months	Time (days) from sleep study device dispatch to treatment decision

Secondary Outcome Measures

Name	Time	Method
AHI	After completion of the sleep studies and data from both devices is available; typically within 1 month but up to 6 months	Apnoea-hypopnoea index compared between sleep study devices; Sunrise and polygraphy
Time to treatment decision; RBH vs NHS Scotland Sleep Service	From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months	Time (days) from sleep study device dispatch to treatment decision; inner London (Royal Brompton hospital) vs Scottish Highlands (NHS Scotland Sleep Service)

Trial Locations

Locations (2)

Raigmore Hospital; 🇬🇧 Inverness, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom