Obstructive Sleep ApneaSOSATNCT05204004
The Sunrise OSA Trial
A study testing Sunrise and Polygraphy in people with Obstructive Sleep Apnea, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Sunrise and Polygraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Aug 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Raigmore Hospital
Inverness, IV2 3UJ
Royal Brompton Hospital
London, SW3 6NP
About this study
Official title: A Prospective, Multicentre, Randomised, Blinded Study of Obstructive Sleep Apnoea Detection Using the Sunrise Solution
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
- Being tested
- Sunrise, Polygraphy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunriseDevice
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.
PolygraphyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment decision
Time (days) from sleep study device dispatch to treatment decision
Measured: 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
Time (days) from sleep study device dispatch to treatment decision; inner London (Royal Brompton hospital) vs Scottish Highlands (NHS Scotland Sleep Service)
Measured: From date of sleep study device dispatch until the date of treatment decision, assessed typically within 1 month but up to 6 months
AHI
Apnoea-hypopnoea index compared between sleep study devices; Sunrise and polygraphy
Measured: After completion of the sleep studies and data from both devices is available; typically within 1 month but up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start21 Aug 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomised, blinded pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Highlands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204004
- Sponsor's protocol ID
- IRAS Project ID: 296444
- Acronym
- SOSAT
- Status last verified
- Mar 2023
- First submitted
- 21 Jun 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Randomised, Blinded Study of Obstructive Sleep Apnoea Detection Using the Sunrise Solution
- ClinicalTrials.gov ID
- NCT05204004
- Acronym / sponsor ID
- SOSAT / IRAS Project ID: 296444
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- NHS Highlands
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, randomised, blinded pilot study
| Arm | Type | Receives |
|---|---|---|
| Sunrise | Experimental | Device: SunriseParticipants 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 | Active comparator | Device: PolygraphyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18
- Ability and willingness to provide informed consent
- Patient referred for suspected OSA
- BMI >28 kg/m2
- Epworth Sleepiness Score >12
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SunriseSunrise (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. | Device | Sunrise |
| PolygraphyPolygraphy (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. | Device | Polygraphy |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunrise and Polygraphy in people with Obstructive Sleep Apnea, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.