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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT07294469
Eligibility Criteria:
Inclusion Criteria:
1. aged between 30 and 80 years (inclusive);
2. diagnosed with idiopathic PD based on the Brain Bank criteria of the UK Parkinson's Disease Society less than 3 years;
3. Hoehn and Yahr stages 1-3 and currently receiving treatment; experiencing sleep disorders with a Pittsburgh Sleep Quality Index (PSQI) \> 5;
4. has signed the informed consent form approved by the Institutional Review Board and dated accordingly;
5. no changes in PD medications within four weeks prior to participating in this trial, and no dosage changes during the study period;
6. able to use other medications that may affect sleep, except those explicitly prohibited, provided the dosage has been stable for the four weeks before screening and remains unchanged during the study.
Exclusion Criteria:
1. menthol allergy;
2. pregnant and breastfeeding women;
3. diagnosed with secondary and atypical PD;
4. patients with conditions such as uremia, cirrhosis, congestive heart failure with pulmonary edema, coagulation disorders, epilepsy, alcoholism, drug abuse, or
5. deemed unsuitable for participation in this study by the principal investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT07294469
Study Brief:
Protocol Section:
NCT07294469