Sleep Well Observation Study
Sleep Disturbance
About this trial
This is an interventional treatment trial for Sleep Disturbance focused on measuring sleep, herbal supplement, pilot trial
Eligibility Criteria
Inclusion Criteria: • Voluntary, written, informed consent to participate in the study. Male or female aged between 18-50 years (inclusive). Self reported sleep problems precursing the criteria of the German "S3 guideline non-restorative sleep/sleep disorders - insomnia in adults". Habitual bedtime between 9 pm and midnight. Agreement to avoid foods such as pitted fruit, bananas and chocolate 24 hours before saliva sample collection. Willing to download wearable app. Easy access to internet for daily e-diary. Cooling capacities available for storage of saliva samples Exclusion Criteria: • Body mass index (BMI) <18.0 or >30.0 kg/m2. Women who are currently pregnant or breastfeeding. Any known history of a disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS) or any organic caused sleep disorders e.g. benign prostatic hyperplasia (BPH), renal insufficiency, hepatopathy, urinary tract infections, irritated bladder, or any psychiatric disorder, e.g. depression, anxiety. Have a significant acute or chronic coexisting illness or any condition which contraindicates entry to the study in the opinion of the Investigator (e.g. migraines, active infections). Previous (last 4 weeks prior to screening) or current intake of drugs that could influence sleep patterns including hormone therapy, health products and oriental herbs. Binge drinking (males >140 g/week, females >70 g/week), heavy smoking (>10 cigarettes/day), high caffeine intake (>10 glasses/day). Self-declared illicit drug use (including cannabis and cocaine) for 3 months prior to screening and during the intervention period. Have a high blood pressure (systolic over 159 mmHg or diastolic over 99 mmHg). Have learning and/or behavioural difficulties such as dyslexia or attention deficit hyperactivity disorder (ADHD). Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness). History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation. Not fluent in German. Have relevant food allergies/intolerances/sensitivities to any substance in the study product. Have oral disease. Participation in another study with any investigational product within 30 days of screening and during the intervention period. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
Sites / Locations
- daacro GmbH & Co. KG
Arms of the Study
Arm 1
Experimental
Sleep Well Sachet "Treatment"
Sachet of Sleep Well direct granulate (2.0 g) 1 sachet contains: 190 mg standardized dry extract of Melissa officinalis leaf , 75 mg dried pressed juice of fresh Lactuca sativa herb, 0.41 g Magnesiumdicitrate, 0.12 g L-Tryptophan, excipients and natural flavors.