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:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT06781593
Eligibility Criteria:
Inclusion Criteria:
* Adults consulting at the MICHEL JOUVET unit, CH Le Vinatier, Bron
* Adults with a diagnosis of major depressive episode (DSM-V) and with a MADRS score ≥ 15
* Adults with a diagnosis of OSAS on ventilatory polygraphy or polysomnography (AASM 2017 criteria) requiring CPAP.
Exclusion Criteria:
* Refusal to participate.
* Pregnant and breast-feeding women
* Under guardianship or curatorship.
* Unstable psychiatric or physical pathology (e.g., hypomania, high suicidal risk) considered incompatible with the study by the investigators.
* Other psychiatric, neurologic or somatic conditions
* Contraindication to light therapy: retinopathy, retinitis pigmentosa, diabetic retinopathy, macular degeneration, glaucoma, recent eye surgery (less than 3 months).
patient wishing to choose a provider other than the protocol provider.
* Patient wishing to choose a device other than SEFAM's S-BOX or a mask other than the nasal mask at the time of introduction.
* Nasal obstruction.
* Refusal to use actimetry, refusal to use light therapy, refusal to use CPAP.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06781593
Study Brief:
Protocol Section:
NCT06781593