healthy volunteers with moderate sleep complaints
Conditions
Interventions
Group 1: 1 tablet Somnum every evening before sleep for 3 weeks
Sponsors
MCM Klosterfrau Vertriebsgesellschaft mbH
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men and women 40-75 years old 2. Moderate sleep complaints within the last year prior to the study, as per investigator’s judgement 3. Body mass index (BMI) 18.5–29.9 kg/m2 4. Generally in good health as judged by the investigator at the screening visit 5. Having access to a smartphone or a computer with an internet access and familiar with the use thereof (checked during the visit) 6. Readiness to comply with study procedures, in particular: • Consumption of the IP • Filling in the subject diary • Keeping bedtime habits, usual diet and level of physical exercise, as well as smoking habits (if any) 7. Women of childbearing potential: • Commitment to use contraception methods • Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1 Participation is based upon written informed consent form (ICF) by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Exclusion criteria
Exclusion criteria: 1. Known sensitivity to any components of the IP 2. Insomnia disorder (ICD-11), as per investigator’s judgement 3. Insomnia severity index score >10 4. Self-reported substantial daily sleepiness (as per investigator's judgement) 5. Less than 5 hours sleep per night on average, self-reported 6. Self-reported regular daytime sleeping (>1 hour daily) 7. Self-reported medical condition associated with sleep complaints, e.g. sleep apnoea, restless legs syndrome, neurological / psychiatric disorder, chronic pain (as per investigator's judgement) 8. Lifestyle and other factors potentially associated with sleep problems, e.g. ex-cessive caffeine intake, (night)shift work, long-distance travelling, significant stressors such as active grieving etc. (as per investigator's judgement) 9. History and/or presence of clinically significant self-reported disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject: • Untreated or non-stabilized diabetes mellitus • Untreated or non-stabilized thyroid gland disorder • Untreated or non-stabilized hypertension (regular systolic blood • pressure =140 mmHg and/or diastolic blood pressure =90 mmHg) • Significant gastrointestinal diseases • Other known significant or serious condition / disease that renders • subjects ineligible (e.g. history of malignancy within the past 5 years • prior to study, any clinically significant cardiovascular, renal, liver • disease etc.) 10. Use of drugs/supplements other than the IP which could interfere with the re-sults of the study as per investigator's judgement (e.g. stimulants, neurolep-tics, benzodiazepines, antidepressants, hypnotics etc.) within the last 4 weeks prior to screening visit and during the study; antihistamines are allowed at a constant dose within the last 4 weeks prior to screening visit and during the study 11. History or current abuse of alcohol or drugs 12. Women of childbearing potential: pregnancy or nursing 13. Participation in another study during the last 4 weeks prior to and during the study 14. Any other reason for exclusion as per investigator's judgment, e.g. expected insufficient compliance with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Subject diary daily sleep related parameters – comparison vs baseline: • time in bed (time of going to sleep - time of waking up) • time to fall asleep (sleep onset latency) • number of awakenings in the night • total duration of wake time during the night (wake after sleep onset) • total sleep time (time in bed – wake time in the night) • sleep efficiency ((total sleep time/time in bed)x100) 2. Subject diary daily sleep related parameters – percentage of subjects with improvement in any of the parameters 3. Subject diary weekly sleep related parameters: mAIS – comparison of values for 1st, 2nd and 3rd week of taking IP vs baseline values 4. Global evaluation of benefit of the IP 5. AEs during the study 6. Global evaluation of tolerability of the IP | — |
Countries
Germany
Contacts
Public ContactRalf Uebelhack
A&R Analyze & Realize GmbH
Outcome results
None listed