Primary insomnia Mental and Behavioural Disorders
Conditions
Interventions
The subjects recruited in the present clinical study consumed a food supplement based on based on melatonin, Withania somnifera (L.) Dunal, L-ornithine, magnesium and Crocus sativus L. (commercial nam
Sponsors
ANTUR S.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-65 years of both sexes 2. Subjects able to understand and sign the informed consent 3. Subjects who have a score between 5 and 7 in the Patient Health Questionnaire-9 (PHQ-9), corresponding to subjects with slightly altered mood, not frankly pathological, whose score in the Patient Health Questionnaire-9 is lower than the maximum limits of subthreshold depression (which has a score of 9 in the PHQ-9) 4. Subjects who present a mild mood alteration (subthreshold depression) (Patient Health Questionnaire-9 between 5 and 7) and who are not eligible to take antidepressant drugs 5. Subjects who do not present anxiety and who have a GAD-7 score =7
Exclusion criteria
Exclusion criteria: 1. Aged 75 years 2. A medical history or condition that could affect the subject's safety or negatively impact the validity of the study results 3. Pregnant or breastfeeding women 4. A history of allergy to ingredients contained in the study treatments (dietary supplement and placebo) 5. Exposed to a high risk of cardiovascular events based on eight risk factors (sex, age, diabetes, smoking habits, systolic blood pressure, total cholesterolemia, HDL-cholesterolemia, and antihypertensive treatment) 6. Following drug therapy for diabetes even at low dosages 7. Taking supplements to control cholesterol, blood sugar, and metabolic syndrome, in the 2 weeks prior to recruitment 8. Women who are suspected to be pregnant or are planning pregnancy 9. Non-self-sufficient individuals 10. Do not show a propensity to collaborate 11. Have difficulty getting to the reference facility within the scheduled time 12. Are not considered suitable by the investigators due to the presence of other pathologies considered incompatible with enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep-wake balance assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire at the start and the end of each study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Insomnia severity assessed using the Insomnia Severity Index questionnaire at the start and the end of each study period. 2. Parameters derived from the sleep diary (self-registered every day): 2.1. Total time in bed (TTB) = time interval in minutes between the time the patient lays down in bed and the time he gets out of bed 2.2. Sleep latency (SOL – sleep onset latency) = time interval (in minutes) between the time the patient gets ready to sleep (turns off the light or the TV) and the time he falls asleep 2.3. Number of awakenings (NR) = number of nocturnal awakenings 2.4. Duration of nocturnal awakenings (WASO – wakefulness after sleep onset) = intra-nocturnal wakefulness given by the overall sum of the wakefulness (in minutes) of nocturnal awakenings 2.5. Total sleep time (TTS) = time interval (in minutes) between the time the patient falls asleep and the time he finally wakes up in the morning minus the overnight wakefulness 2.6. Sleep Efficiency Index (SEI) = TTS/TTB*100 3. Pain assessed using the Visual Analog Scale (VAS) at the start and the end of each study period | — |
Countries
Italy
Contacts
Public ContactFabiana Antoniali
Outcome results
None listed