To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions.
One-hundred-forty participants with self-reported insomnia (PSQI≥ 7 \& 22 \> ISI ≥ 12) aged between 20 and 60 years old are estimated to be recruited and randomly assigned to two arms, the PS150 group and the placebo group, under the double-blinded trial. Participants take one capsule of probiotics or placebo after dinner for 30 days. Study measures include polysomnography (PSG), subjective sleep, depressive, and anxiety questionnaires, sleep diary, fecal sampling, saliva testing, and urine testing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
140
Institute of Brain Science National Yang Ming Chiao Tung University
Taipei, Taiwan
RECRUITINGPolysomnography (PSG)
According to the polysomnography, we can analysis participants' brain waves (alpha,beta,theta,delta), sleep stages, and autonomic nervous system functioning to evaluate their objective sleep quality.
Time frame: Baseline, day30
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated inventory that assesses sleep quality over the past 1-month. The measure consists of 19 individual items, creating 7 components that produce one global score. It takes 5-10 minutes to complete.The maximum global score is 21. A higher score reflects more poor sleep quality.
Time frame: Baseline, day 30
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is designed as a brief screening tool for insomnia. The seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a 5-Likert scale. Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia.The maximum total score is 28.
Time frame: Baseline, day 30
Beck Depression Inventory-Second Edition (BDI-II)
The Beck Depression Inventory-Second Edition (BDI-II) is a 21-item, self-rated inventory that evaluates key symptoms of depression. It rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. A higher score reflects greater symptoms of depression.
Time frame: Baseline, day 30
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) is a 21-item, self-rated inventory that evaluates anxiety levels. It rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related anxious symptoms.The maximum total score is 63. A higher score reflects greater symptoms of anxiety.
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Time frame: Baseline, day 30
VAS-Sleep
Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm).
Time frame: Baseline, day 30
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of sleepiness. It is a list of eight situations in which you rate your tendency to become sleepy. Each item is rated on the scale from 0, no chance of dozing, to 3, high chance of dozing.
Time frame: Baseline, day 30
Stanford Sleepiness Scale (SSS)
The Stanford Sleepiness Scale (SSS) is a 7-point Likert inventory to evaluate a respondent's sleepiness at the time when it is completed.
Time frame: Baseline, day 30
Visual Analogue Scale for gastrointestinal symptoms (VAS-GI)
Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in respondents before and after taking PS150 or Placebo.
Time frame: Baseline, day 30
Saliva Melatonin
pg/ml of melatonin in saliva measured by enzyme-linked immunosorbent assay.
Time frame: Baseline, day 30
Saliva Cortisol
Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help: body respond to stress or danger increase your body's metabolism of glucose control your blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by your body to ensure the balance is correct.
Time frame: Baseline, day 30
Saliva Interleukin-6 (IL-6)
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify IL-6 amount (ng/mL).
Time frame: Baseline, day 30
Saliva Total Antioxidant Capacity (TAC)
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify TAC amount (nmol/mL).
Time frame: Baseline, day 30
Saliva Serotonin
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify serotonin amount (ng/mL).
Time frame: Baseline, day 30
Saliva gamma-aminobutyric acid (GABA)
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify GABA amount (pg/mL).
Time frame: Baseline, day 30
Saliva Orexin
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify Orexin amount.
Time frame: Baseline, day 30
Urine 6-sulfatoxymelatonin
In order to determine the levels of 6-sulphatoxymelatonin from patients in the experimental and control groups, urine samples will be taken between between 21:00 to 23:00 at night. A urine sample will be taken into a sample container containing 10-15 ml of 6 M hydrochloric acid (HCl) and stored at -80 degrees for analysis in the biochemistry laboratory.
Time frame: Baseline, day 30
Urine Norepinephrine
In order to determine the levels of norepinephrine from patients in the experimental and control groups, urine samples will be taken between between 21:00 to 23:00 at night. A urine sample will be taken into a sample container containing 10-15 ml of 6 M hydrochloric acid (HCl) and stored at -80 degrees for analysis in the biochemistry laboratory.
Time frame: Baseline, day 30
Actigraphy
Actigraph will be placed on the non-dominant wrist and activities will be monitored continuously and recorded at one minute intervals during wakefulness and sleep. The times of wakefulness and sleep will be determined individually through a diary kept by the participants, together with the times calculated by the actigraph monitor. The participants will keep the device for a period of 7 days before and the last 7-day of training session. The device will be removed only at bath time and replaced to the wrist immediately after.
Time frame: Baseline, day 30
Sleep Diary
The sleep diary is a daily self-reported 12-item form within 30 minutes after wake up. It assesses respondent's time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency, etc.
Time frame: Baseline, day 30