The Sunrise OSA Trial (SOSAT)

Royal Brompton & Harefield NHS Foundation Trust

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Sunrise; Device: Polygraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT05204004

IRAS Project ID: 296444

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Sunrise

Experimental group

Description:

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.

Treatment:

Device: Sunrise

Polygraphy

Active Comparator group

Description:

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.

Treatment:

Device: Polygraphy