The Sunrise OSA Trial

NCT05204004 | Completed

• 1 other identifier: IRAS Project ID: 296444
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Time to treatment decision

  Time (days) from sleep study device dispatch 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

Secondary Outcomes (2)

• 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

• AHI

  After completion of the sleep studies and data from both devices is available; typically within 1 month but up to 6 months

Study Arms (2)

Sunrise

EXPERIMENTAL

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.

Device: Sunrise

Polygraphy

ACTIVE COMPARATOR

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.

Device: Polygraphy

Interventions

Sunrise DEVICE

Sunrise (Sunrise SA, Belgium) is a novel integrated digital medicine solution for the diagnosis of OSA allowing the detection of respiratory disorders from the analysis of mandibular movements optimised by an artificial intelligence algorithm "machine learning". It is composed of a unique innovative sensor, placed on the chin during the night, connected via Bluetooth to a mobile application which guides the patients for the implementation and allows the transfer of the data collected by the sensor to a certified health host guaranteeing the security and confidentiality of medical data. The analysed data is integrated and automatically transferred into a detailed report made available to doctors via a secure website the day after the test.

Sunrise

Polygraphy DEVICE

Polygraphy (Apnoealink-Air, ResMed, Australia) is a commercially available, limited-channel sleep study device which can be used in the home. Many sleep services in the UK already use the ApneaLink Air for routine screening. It is a portable device which consists of a nasal cannula to measure nasal flow and snoring, oximeter to measure pulse and blood oxygen levels, and a chest band to measure respiratory effort. It contains software which allows for the scoring of apnoeas, hypopnoea and arousals.

Polygraphy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient already treated for OSA
• Patient has PSV or HGV driving license
• Unstable cardiac disease
• Supplemental oxygen
• Known secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome
• 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
• Pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
• Patient whose beard is too thick to wear the Sunrise device, and who does not wish to shave
• Patient with acrylic or painted fingernails, who does not wish to remove acrylic or paint

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• NHS Highlands: collaborator

Study Sites (2)

Raigmore Hospital

Inverness, IV2 3UJ, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients under investigation for OSA will use both devices (Sunrise solution and overnight polygraphy) simultaneously for a single overnight sleep study. They will be randomised to receive their treatment decision based on either the Sunrise solution or polygraphy. They will be unaware of which device their treatment decision was based on.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomised, blinded pilot study

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: January 24, 2022
• Study Start: August 21, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)