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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT04198493
Eligibility Criteria:
Inclusion Criteria:
* Subjects of both sexes with ages over 18 years old with DS.
* A good general health with adequate visual and auditory acuity will be required
* Understanding and accepting the study procedures and signing an informed consent (guardian and / or patient).
* intelligence quotient(IQ) ratio\> 34 (mild and moderate severe intellectual disability according to the International Statistical Classification of Diseases and Related Health Problems, ICD-10, criteria).
* Subjects without dementia: Absence of loss of cognitive functions (demonstrated by the longitudinal administration of neuropsychological tests and verified by family members)
* Absence of psychiatric comorbidity
Exclusion Criteria:
* Severe intellectual disability (due to limitations in cognitive tests)
* Presence of psychiatric pathology, unstable disease, cardiac or respiratory failure.
* Intake of psychoactive drugs in the three months prior to the study.
* Patients diagnosed with OSA, undergoing treatment with CPAP.
* Subjects with an Epworth Sleep Scale score \> 12
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04198493
Study Brief:
Protocol Section:
NCT04198493