Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia

Official title

Effect of Lactium on Sleep Efficiency and Quality in Healthy Volunteers With Persistent Subclinical Insomnia

Overview

The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia.

Interventions

• Dietary supplement Lactium
  300 mg per day, taken 30 min to 60 min before bedtime
• Dietary supplement Placebo
  300 mg per day, taken 30 min to 60 min before bedtime

Primary outcome measures

• Sleep efficiency [Time frame: Before treatment (day 0); at the end of the treatment (after 29 days)]

Secondary outcome measures (4)

• Sleep diary [Time frame: Before treatment (day 0); at the end of the treatment (after 29 days)]
• Insomnia Severity Index [Time frame: Before treatment (day 0); at the end of the treatment (after 29 days)]
• PSQI [Time frame: Before treatment (day 0); at the end of the treatment (after 29 days)]
• Sleep quality by cctigraphy [Time frame: Before treatment (day 0); at the end of the treatment (after 29 days)]

Eligibility criteria

Inclusion criteria

• In good general and mental health according to the investigator judgement: no clinically significant and abnormalities relevant to medical history or clinical examination
• Having a Body Mass Index (BMI) of 18.5 < BMI < 30 kg/m2
• Present subclinical insomnia characterized by an Insomnia Severity Index (ISI) score between 8 and 14 during the last month preceding the screening visit
• Whose insomnia symptoms started at least 3 months before the screening visit
• Present a medium level of phycological stress characterized by a Perceived Stress Scale (PSS-10) score between 14 and 26
• Willing / able to maintain their eating habits and physical activity during the study (no planned diet, no change in physical activity ...)
• Willing / able to participate in the study in accordance with protocol procedures (dated and signed informed consent form)
• Affiliated to a Health insurance scheme
• Agree to be registered in the national database of subjects participating in clinical research
• Have a smartphone compatible with the NursTrial® e-PRO application

Exclusion criteria

• Presenting moderate to severe insomnia defined by an ISI score greater than or equal to 15 in the last month prior to selection
• Presenting other sleep disorders already diagnosed or suspected during the screening visit: impatience (restless legs), parasomnias, hypersomnias, sleep apnea, iatrogenic insomnia
• Subject assessed as "definitely" an evening type people by the Horne and Ostberg's circadian typology questionnaire (delayed phase subject)
• Whose sleep disorders are related to external factors (noise pollution, young children, etc ...)
• Workers with atypical schedules (night work, staggered working hours, changes in regular working hours, or shift work)
• Smoker
• Drug Addict
• Alcohol consumption greater than 2 glasses per day
• Subject with excessive caffeine consumption exceeding 400 mg per day (coffee ≈ 80 mg per cup; cola soda≈ 25 mg per glass; tea ≈40 mg per cup; energy drinks ≈70 mg per glass)
• Subject consuming or having consumed any dietary supplement with an effect or a possible effect on sleep, stress, anxiety, or fatigue during the last 3 months prior to screening visit (melatonin, lactium, ginseng, caffeine ...)
• Subject who has been treated during the 6 months preceding the screening visit or are currently being treated with non-medication therapies (such as psychotherapy, Cognitive Behavioral Therapy \[CBT\], Eye Movement Desensitization and Reprocessing \[EMDR\], etc. or repetitive Transcranial Magnetic Stimulation \[TMS\]) or psychotropic medication prescribed and / or recommended for anxious manifestations, depression, sleep disorders and generally for any neurological or psychological manifestation
• Subject with psychiatric comorbidity as described in the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) (depression, post traumatic stress disorder, etc.) or history of psychiatric illness
• Untreated or not controlled hypertension
• Untreated or not controlled thyroid diseases (hypo or hyperthyroidism, Graves' disease...)
• Epileptic subject
• Asthmatic subject
• Any other pathology or medical history or symptomatology likely to significantly influence the study criteria (nocturnal pain, nasal congestion, cough at bedtime or nocturnal cough, nocturnal pollakiuria, tinnitus, etc.) according to the investigator
• Confirmed cow's milk protein allergy
• Sleeping on a mattress that is not compatible with the sleep quality recording (water and air mattresses) or does not have adequate or necessary domestic equipment for its operation (power socket near the bed, etc.)
• Likely to sleep outside their home during the study (holidays, regular business trips, etc.)
• Whose spouse or partner is participating in this study
• Pregnant woman (negative urine test at screening and initial/randomization visits) or wishing to be pregnant during the study or breastfeeding
• Hormonal state that may induce fluctuation in emotional state and sleep during the study, such as, the postpartum period (< 6 months after delivery) and perimenopause (irregular menstrual cycle, hot flashes)
• Under legal protection (guardianship, curatorship) or deprived of rights following an administrative or judicial decision
• Psychologically or linguistically incapable of understanding and signing informed consent
• Participating in another clinical trial or in exclusion period of a previous clinical trial
• Having reached the maximum research compensation threshold stipulated by regulations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06378034 · 2023-A01926-39

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗