Chronic Insomnia, Polysomnography
Conditions
Keywords
Alpha-s1 casein hydrolysate, Randomized controlled trial, insomnia, Polysomnography
Brief summary
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.
Detailed description
During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.
Interventions
DIETARY_SUPPLEMENTalpha-s1 casein hydrolysate
150mg of Prelactium per capsule
DIETARY_SUPPLEMENTMaltodextrin
150mg of Maltodextrin per capsule
Sponsors
Kuang Tien General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition); 2. PSQI score greater than 5; 3. participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form.
Exclusion criteria
1. currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks); 2. patients with a history of significant head trauma; 3. individuals with alcohol abuse within the past year; 4. those with other severe medical conditions (e.g., hepatic or renal dysfunction); 5. Pregnant women or breastfeeding mothers; 6. participants unable to comply with the trial schedule; 7. individuals on a vegetarian diet; 8. those with allergies to dairy products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 2nd and 4th week | A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia. |
| Pittsburgh Sleep Quality Index (PSQI) | 2nd and 4th week | A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality. |
| Epworth Sleepiness Scale (ESS) | 2nd and 4th week | 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. |
| General Sleep Disturbance Scale (GSDS) | 2nd and 4th week | A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance). |
| Hospital Anxiety and Depression Scale (HADS) | 2nd and 4th week | A sleep-related questionnaire, ranging from 0 to 21. A total score of \>8 points denotes considerable symptoms of anxiety or depression. |
| Sleep quality | baseline and 4th week | Polysomnography (PSG) |
Countries
Taiwan
Outcome results
None listed