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This study investigates the impact of Aalpha-s1 casein hydrolysate (ACH; Lactium®) on sleep quality in individuals with chronic insomnia, employing both subjective sleep profiles and objective polysomnography (PSG) recordings.
During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACH (Aalpha-s1 casein hydrolysate) | Experimental | Each participant will take Prelactium capsules (alpha-s2 casein hydrolysate supplement; 150mg per capsule) 30 minutes before bedtime for a duration of 4 weeks: 4 capsules in the first two weeks and 2 capsules in the last two weeks. |
|
| Placebo (Maltodextrin) | Placebo Comparator | Each participant will take Maltodextrin capsules (150mg per capsule) 30 minutes before bedtime for a duration of 4 weeks: 4 capsules in the first two weeks and 2 capsules in the last two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpha-s1 casein hydrolysate | Dietary Supplement | 150mg of Prelactium per capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia. | 2nd and 4th week |
| Pittsburgh Sleep Quality Index (PSQI) | A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality. | 2nd and 4th week |
| Epworth Sleepiness Scale (ESS) | A sleep-related questionnaire, ranging from 0 to 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness. | 2nd and 4th week |
| General Sleep Disturbance Scale (GSDS) | A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance). | 2nd and 4th week |
| Hospital Anxiety and Depression Scale (HADS) | A sleep-related questionnaire, ranging from 0 to 21. A total score of >8 points denotes considerable symptoms of anxiety or depression. | 2nd and 4th week |
| Sleep quality | Polysomnography (PSG) | baseline and 4th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuang Tien General Hospital | Taichung | 433 | Taiwan |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | 150mg of Maltodextrin per capsule |
|
| D001523 |
| Mental Disorders |