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 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT03037203
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
2. Hoehn and Yahr stage 1, 2, or 3.
3. Screening and Baseline ESS scores \>11.
Exclusion Criteria:
1. Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy \[MSA\], or dementia with Lewy bodies \[DLB\]).
2. Usual nightly time in bed of \<6 hours, including the night before the Baseline visit.
3. Untreated or inadequately treated moderate to severe OSA.
4. Has evidence at screening of severe cognitive impairment or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT03037203
Study Brief:
Protocol Section:
NCT03037203