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Compares treatment options for Obstructive Sleep Apnoea (OSA)
Official title A Study Assessing Adult Patients Referred to an NHS Sleep Service With Suspected Obstructive Sleep Apnoea. This Study Aims to Compare the Sunrise Wearable Diagnostic Device Performance and Potential Inclusion in a NHS Diagnostic Pathway With Oximetry and WatchPAT Which Are Currently Used.
ClinicalTrials.gov ID: NCT07269483
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate whether the Sunrise device (that measure small jaw movements) can improve the diagnosis and management of Obstructive Sleep Apnoea (OSA) in adults (≥ 18 years) referred to a Sleep Clinic. The main question it aims to answer are: \- Does Sunrise lead to a higher proportion of definitive management decisions (initiate OSA treatment, discharge from the sleep clinic service, additional diagnostic testing required or a clinic appointment) compared to current screening practices, which includes either overnight oximetry or use of a wearable device called WatchPAT 300?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults (aged ≥18 years old) referred with suspected Obstructive Sleep Apnoea
- Patient has capacity to provide informed consent
- Patient has access to a smartphone with Bluetooth and WiFi or internet data to download the Sunrise app and to transmit the Sunrise results to the...
- Willing and able to comply with the study-specific procedures
- Ability to read and comprehend English or understand simple device user instructions with guided pictures in English.
You likely can't join if
- Suspected diagnosis of a sleep disorder other than OSA (including central sleep apnoea, parasomnias, narcolepsy, idiopathic hypersomnia)
- Suspected chronic hypercapnic respiratory failure (history of acute hypercapnic respiratory failure, raised CO2 or serum bicarbonate)
- Patients with unstable cardiovascular disease or non-arteritic anterior ischaemic optic neuropathy
- Patients with beards who are unwilling to shave the area below their lip (the soul patch)
- Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint
- Unable to consent or lacks capacity to provide informed consent
See the full eligibility criteria
- Adults (aged ≥18 years old) referred with suspected Obstructive Sleep Apnoea
- Patient has capacity to provide informed consent
- Patient has access to a smartphone with Bluetooth and WiFi or internet data to download the Sunrise app and to transmit the Sunrise results to the Sunrise portal. UHBW Trust Wi-Fi available to the patient at equipment...
- Willing and able to comply with the study-specific procedures
- Ability to read and comprehend English or understand simple device user instructions with guided pictures in English.
- Suspected diagnosis of a sleep disorder other than OSA (including central sleep apnoea, parasomnias, narcolepsy, idiopathic hypersomnia)
- Suspected chronic hypercapnic respiratory failure (history of acute hypercapnic respiratory failure, raised CO2 or serum bicarbonate)
- Patients with unstable cardiovascular disease or non-arteritic anterior ischaemic optic neuropathy
- Patients with beards who are unwilling to shave the area below their lip (the soul patch)
- Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint
- Unable to consent or lacks capacity to provide informed consent
- In-patient referrals
- Unwilling or unable to comply with the study-specific procedures.
- Patients who have requested in their medical notes not to be involved in research or not to receive digital communication
The study team makes the final eligibility decision.
Where it's taking place
- Bristol, South West, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bristol, South West, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.