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The Sunrise OSA Trial (SOSAT)

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Sunrise

Polygraphy

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Raigmore Hospital
Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sunrise

Polygraphy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to treatment decision

Time (days) from sleep study device dispatch to treatment decision

Secondary Outcome Measures

Time to treatment decision; RBH vs NHS Scotland Sleep Service

Time (days) from sleep study device dispatch to treatment decision; inner London (Royal Brompton hospital) vs Scottish Highlands (NHS Scotland Sleep Service)

AHI

Apnoea-hypopnoea index compared between sleep study devices; Sunrise and polygraphy

Full Information

NCT ID

NCT05204004

First Posted

June 21, 2021

Last Updated

March 29, 2023

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

NHS Highlands

1. Study Identification

Unique Protocol Identification Number

NCT05204004

Brief Title

The Sunrise OSA Trial

Acronym

SOSAT

Official Title

A Prospective, Multicentre, Randomised, Blinded Study of Obstructive Sleep Apnoea Detection Using the Sunrise Solution

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 21, 2021 (Actual)

Primary Completion Date

March 1, 2023 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

NHS Highlands

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A prospective, randomised, blinded pilot study

Masking

Participant

Masking Description

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.

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sunrise

Arm Type

Experimental

Arm Description

Arm Title

Polygraphy

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Sunrise

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Polygraphy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to treatment decision

Description

Time (days) from sleep study device dispatch to treatment decision

Time Frame

From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months

Secondary Outcome Measure Information:

Title

Time to treatment decision; RBH vs NHS Scotland Sleep Service

Description

Time (days) from sleep study device dispatch to treatment decision; inner London (Royal Brompton hospital) vs Scottish Highlands (NHS Scotland Sleep Service)

Time Frame

From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months

Title

AHI

Description

Apnoea-hypopnoea index compared between sleep study devices; Sunrise and polygraphy

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Raigmore Hospital

City

Inverness

ZIP/Postal Code

IV2 3UJ

Country

United Kingdom

Facility Name

Royal Brompton Hospital

City

London

ZIP/Postal Code

SW3 6NP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Sunrise OSA Trial

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