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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05829902
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 35-60
* BMI 18-30 kg/m2
* Mild to moderate insomnia according to the ISI (Insomnia Severity Index) questionnaire (ISI-value 10-21)
* Matching results from the Oura ring and sleep diaries during the run-in period
Exclusion Criteria:
* Metabolic disease (diabetes, cardiovascular disorders, hypo- or hyperthyroidism, etc)
* Severe psychiatric disorders
* Pregnancy, breastfeeding
* Restless legs or leg cramps that influence sleep and everyday life
* Conditions that prevent sleep through the symptoms that they produce (pain, nightly coughs, etc)
* Breathing problems (asthma, severe snoring, sleep apnea, etc)
* Medication that can influence sleep and/or wakefulness
* Consumption of herbal sedatives during the last month
* Having someone in the household that needs to be tended to during the night and pose a major risk to disturb the research participant's sleep to a large extent.
* Irregular work hours, including shift work at night
* Regularly sleeping more than 1 night per week away from home
* Tobacco or drug use
* Other factors that are deemed to influence participation negatively
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT05829902
Study Brief:
Protocol Section:
NCT05829902