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 @ 10:31 PM
Ignite Modification Date:
2025-12-24 @ 10:31 PM
NCT ID:
NCT03814135
Eligibility Criteria:
Inclusion Criteria:
* Participants aged 50 years or more;
* Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
* Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.
Exclusion Criteria:
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Known hypersensitivity to the formula components used during the clinical trial;
* Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
* History of hepatic impairment;
* Current smoking;
* Pregnancy or risk of pregnancy and lactating patients;
* History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;
* Diagnosis of clinical diseases that interfere with sleep;
* Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;
* Participation in clinical trial in the year prior to this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03814135
Study Brief:
Protocol Section:
NCT03814135