The Sunrise OSA Trial

Obstructive Sleep Apnea Clinical Trial

— SOSAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05204004
• Other study ID #: IRAS Project ID: 296444
• Status: Completed
• Phase: N/A
• Start date: August 21, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Sunrise
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
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.

Locations

Country	Name	City	State
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	Royal Brompton Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	NHS Highlands

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months
Secondary	AHI	Apnoea-hypopnoea index compared between sleep study devices; Sunrise and polygraphy	After completion of the sleep studies and data from both devices is available; typically within 1 month but up to 6 months