Status:
COMPLETED
The Sunrise OSA Trial
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
NHS Highlands
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05204004
Start Date
August 21 2021
End Date
March 1 2023
Last Update
March 30 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Raigmore Hospital
Inverness, United Kingdom, IV2 3UJ
2
Royal Brompton Hospital
London, United Kingdom, SW3 6NP