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Completed

NCT Number: NCT05204004

The Sunrise OSA Trial

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raigmore Hospital, Inverness, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Time 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

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

Secondary outcomes

  1. Time to treatment decision; RBH vs 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

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

  2. AHI

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Collaborators

  • NHS Highlands

Registry information

Official study title

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

Acronym: SOSAT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2022
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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