Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT05204004
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05204004
Study Brief:
Protocol Section:
NCT05204004