BridgeMD
Tests treatment safety and results for Sleep Onset Latency
Official title Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
ClinicalTrials.gov ID: NCT06600633
What this study is testing
- What it's testing
- single-center, randomized, cross over, double-blind, placebo controlled intervention study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 24 to 65. Healthy volunteers may be eligible.
You may be able to join if
- subject Informed consent form (ICF) is signed
- aged 24-65 years at the time of the signature of ICF
- suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI higher than 5
- no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9
- a body mass index (BMI) up to 32 kg/m2
You likely can't join if
- diagnosed or subject to therapy due to sleep disorders
- acute infectious disease
- any kind of chronic pharmacological therapy with antihypertensives or antidepressants
- any kind of other pharmacological therapy that could interact with active ingredients used in the study
- pregnancy or planned pregnancy, lactation, menopause (with clinically relevant symptoms/therapy)
- use of beta-blockers
See the full eligibility criteria
- subject Informed consent form (ICF) is signed
- aged 24-65 years at the time of the signature of ICF
- suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI higher than 5
- no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9
- a body mass index (BMI) up to 32 kg/m2
- stable medications for non excluded concurrent medical conditions for six weeks prior to the screening visit
- ability to ingest oral food supplement (study product)
- willing to follow all study procedures, including attending all site visits and use of actigraphy
- diagnosed or subject to therapy due to sleep disorders
- acute infectious disease
- any kind of chronic pharmacological therapy with antihypertensives or antidepressants
- any kind of other pharmacological therapy that could interact with active ingredients used in the study
- pregnancy or planned pregnancy, lactation, menopause (with clinically relevant symptoms/therapy)
- use of beta-blockers
- chronic use of use of prostaglandin synthesis inhibitors (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen
- supplementation with melatonin or other food supplements intendent for sleep quality during last 2 weeks
- unwillingness to maintain caffeine abstinence after 4:00 PM during the study
- not having a mobile upper extremity for attaching an actigraph
- known alcohol and/or drug abuse
- unwillingness to comply with the maximum limit of 2 alcoholic drinks per day, and only up to 1 alcoholic drink after 6:00 PM during the study
- known lactose/gluten intolerances/food allergies
- known gastrointestinal disease
- less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
- have stomach or bowel resection
- night work (including as part of shift work)
- mental incapacity that precludes adequate understanding or cooperation
- participation in another investigational study
The study team makes the final eligibility decision.
Where it's taking place
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 24 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.