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The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactium | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactium | Dietary Supplement | 300 mg per day, taken 30 min to 60 min before bedtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency | The primary endpoint will be changes between baseline and final sleep efficiency (SE), measured nightly using actigraphy | Before treatment (day 0); at the end of the treatment (after 29 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary | Changes between baseline and final subjective sleep quality parameters, recorded in the sleep diary | Before treatment (day 0); at the end of the treatment (after 29 days) |
| Insomnia Severity Index |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Dietary Supplement |
300 mg per day, taken 30 min to 60 min before bedtime |
|
Changes between the baseline and intermediate and final values of the Insomnia Severity Index (ISI) total score Present subclinical insomnia characterized by an Insomnia Severity Index (ISI) score between 8 and 14 e. The sub-scores of the ISI correspond to 0-7: Lack of insomnia, 8-14: Subthreshold (=subclinical) insomnia, 15- 21: Moderate insomnia, 22-28: Severe insomnia.
| Before treatment (day 0); at the end of the treatment (after 29 days) |
| PSQI | Changes between the baseline and final values of Pittsburgh Sleep Quality Index (PSQI) total score Score 0: no sleep diroders, >5 moderate sleep disorders; 21: severe sleep disorders | Before treatment (day 0); at the end of the treatment (after 29 days) |
| Sleep quality by cctigraphy | Changes between baseline and final objective sleep quality by actigraphy | Before treatment (day 0); at the end of the treatment (after 29 days) |
| D001523 | Mental Disorders |