An interventional study of alpha-s1 casein hydrolysate and Maltodextrin in Chronic Insomnia and Polysomnography, sponsored by Kuang Tien General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by Kuang Tien General Hospital · Not applicable, Interventional, and Prevention
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 38 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Kuang Tien General Hospital is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: alpha-s1 casein hydrolysate
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.
Dietary Supplement: Maltodextrin
150mg of Prelactium per capsule
Also known as: Prelactium
150mg of Maltodextrin per capsule
Insomnia Severity Index (ISI)
A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Time frame: 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.
Time frame: 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.
Time frame: 2nd and 4th week
General Sleep Disturbance Scale (GSDS)
A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance).
Time frame: 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.
Time frame: 2nd and 4th week
Sleep quality
Polysomnography (PSG)
Time frame: baseline and 4th week
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Kuang Tien General Hospital