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Completed

NCT Number: NCT06199596

Alpha-s1 Casein Hydrolysate on Sleep

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.

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Polysomnography Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuang Tien General Hospital

Taichung, 433, Taiwan

About this study

During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition);
  • PSQI score greater than 5;
  • participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form.

Exclusion criteria

  • currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks);
  • patients with a history of significant head trauma;
  • individuals with alcohol abuse within the past year;
  • those with other severe medical conditions (e.g., hepatic or renal dysfunction);
  • Pregnant women or breastfeeding mothers;
  • participants unable to comply with the trial schedule;
  • individuals on a vegetarian diet;
  • those with allergies to dairy products.

Treatment and study plan

alpha-s1 casein hydrolysate

Dietary Supplement

150mg of Prelactium per capsule

Other names: Prelactium

Maltodextrin

Dietary Supplement

150mg of Maltodextrin per capsule

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 2nd and 4th week

    A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 2nd and 4th week

    A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.

  3. Epworth Sleepiness Scale (ESS)

    Time frame: 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.

  4. General Sleep Disturbance Scale (GSDS)

    Time frame: 2nd and 4th week

    A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance).

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  6. Sleep quality

    Time frame: baseline and 4th week

    Polysomnography (PSG)

Sponsors and collaborators

Lead sponsor

Kuang Tien General Hospital

Other

Registry information

Official study title

The Effect of Alpha-s1 Casein Hydrolysate for Patients With Chronic Insomnia: A Randomized Double-Blind Controlled Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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