Improvement of sleep quality in participants with insomnia Nervous System Diseases
Conditions
Interventions
This study investigates 4 weeks of daily supplementation with ETAZEO (250 mg capsule) or a placebo (dextrin, 250 mg capsule) taken orally in the evening before sleep. Block randomization was used to a
Sponsors
INNOVATION LABO Sciences Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy non-smoker Asian male and female subjects between 25-65 years old (inclusive) 2. Presence of chronic disturbed sleep (PSQI >5) 3. Presence of chronic snoring. A patient is considered a chronic snorer if his/her bedmate/roommate reported snoring more than 5 days per week and if this is corroborated by medical analysis performed in the patient’s own home. The result of the respiratory polygraphy should indicate the presence of snoring during at least 30% of the nocturnal period. 4. Have a regular roommate or bedmate to submit information 5. Subjects available during the whole period of study (1 month)
Exclusion criteria
Exclusion criteria: 1. Subjects with sleep apnoea 2. High-risk professions and/or controlling dangerous machines 3. Moderate or severe somnolence during day time 4. Coronary cardiopathy, acute vascular disease (less than three months), chronic and severe obstructive pulmonary disease, and chronic treatment with theophyllines 5. Temporo-mandibular joint problems or periodontitis 6. Mandibular protrusion capacity less than 6 mm and/or less than 10 teeth in each jaw 7. Severe cognitive disorders and/or patients whose answers to the questionnaires will be altered by chronic and severe diseases 8. Pregnancy (since the third month of pregnancy to 3 months after birth delivery) 9. Patients on prolonged medication(more than 6 weeks) with sleep medication, corticosteroids, antidepressants, anticholinergics, antipsychotic drugs, etc. or any other drugs that may have an influence on the outcome of the study 10. Pregnant/lactating women 11. Subjects who cannot agree to refrain from alcohol consumption during the study period 12. Alcoholics and/or drug abusers 13. Subjects having history of psychiatric disorders that may impair the ability to provide written informed consent 14. Patients who have completed participation in any other clinical trials during the past 3 months 15. Any other conditions that the Principal Investigator thinks may jeopardize the study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sleep score measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire at baseline and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in snoring score measured using the Snoring Severity Scale (SSS) questionnaire at baseline and week 4 | — |
Countries
France
Contacts
Public ContactCeline Klotz
Outcome results
None listed