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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT04054050
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of MS
* Evidence of sleep disturbance
* Stable on immunomodulatory MS therapy or no therapy for at least 6 months prior to study initiation
* Stable on antidepressants for at least 3 months prior to study initiation and no evidence
* Stable on fatigue medication for at least 3 months prior to study initiation
* Willing and able to provide informed consent and follow study procedures.
Exclusion Criteria:
* Evidence of cognitive impairment
* Low risk for sleep disordered breathing
* Other comorbid ophthalmologic disorders (e.g. cataracts, glaucoma, blindness)
* Traveled across two time zones within 90 days of study screening.
* Not participating in shift work
* MS relapse or history of acute optic neuritis within 30 days
* No prior history of bipolar disorder
* No evidence of current depression
* Diagnosis of severe periodic limb movement disorder or severe restless legs syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04054050
Study Brief:
Protocol Section:
NCT04054050