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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT04048603
Eligibility Criteria:
Inclusion Criteria:
for iRBD at baseline:
1. Fulfilling the diagnostic criteria for iRBD. As patients with iRBD were recruited during a long period, the diagnosis of RBD was based on ICSD and ICSD-2 (before 2014), and ICSD-3 (2014 and thereafter) criteria. The diagnosis for all patients were confirmed by video-PSG. In summary, patient diagnosed with RBD should present excessive EMG activity during REM sleep on video-PSG assessment and report a history of repeated dream enactment behaviors;
2. Having neurocognitive test and neurological examination since 2008;
3. Free of neurodegenerative diseases at the last visit.
for controls without iRBD at baseline:
1. Age- and sex- matched with patients with iRBD;
2. Free of narcolepsy and other neurological diseases;
3. Without any RBD features as confirmed by both clinical history and video-PSG;
4. Without neurodegenerative diseases;
5. Having neurocognitive test and neurological examination at baseline.
Exclusion Criteria:
1. Patients with narcolepsy;
2. Patients with known neurodegenerative diseases;
3. Pseudo-RBD (e.g., RBD symptoms were eliminated after severe obstructive sleep apnea had treated with continuous positive airway pressure therapy.);
4. Early-onset RBD (e.g., before the age of 50 years old) which might have a different pathogenesis from iRBD.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04048603
Study Brief:
Protocol Section:
NCT04048603