Sleep
Conditions
Brief summary
A human trial with blind method and self-control design was carried out to evaluate the sleep-improving function of a food. Indicators were detected by professional instruments and self-assessed by subjects. Relevant data before and after 28 consecutive days of test sample administration were collected for comparative analysis.
Detailed description
The objective of this clinical trial is to evaluate whether a food product has the effect of improving sleep. The primary research question is: does a full course of consumption improve sleep outcomes in study participants? This is a single-arm trial comparing participants' sleep status before and after consumption of the test product. Study participants will: Consume the test article daily for 28 consecutive days Attend clinic assessments at baseline (prior to trial initiation) and after the 28-day intervention period Maintain daily sleep diaries throughout the study period
Interventions
OTHERSleep-improving Functional Food
28 days of daily consumption of test functional food; sleep assessment via baseline check-up and daily sleep diaries, single-arm self-controlled study.
Sponsors
Sirio Pharma Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single-arm, pre-post intervention study. Participants consume the test food daily for 28 consecutive days, with baseline and end-of-study clinic assessments and daily sleep diary recording, using each participant as their own control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 60 years of any gender, with a history of staying up late or mild sleep disorder, and Pittsburgh Sleep Quality Index (PSQI) score between 7 and 15 points (mild to moderate sleep impairment). * Regular daily schedule with bedtime from 22:00 to 24:30 and wake-up time from 6:30 to 8:30; long-term daily schedule fluctuation ≤ 2 hours, and able to maintain a fixed schedule throughout the trial. * No abnormal saliva secretion and capable of completing saliva sample collection independently and normally. * Body Mass Index (BMI) ranging from 18.5 to 28.0, without extreme emaciation or obesity. * Able to participate in pre-trial centralized training and operational assessments (including wearable bracelet wearing, saliva collection, and questionnaire filling), and pass the assessment before enrollment. * No intake of sleep aids, anti-anxiety drugs, antidepressants, central nervous system regulators, sleep-improving health foods and related products within 2 weeks prior to enrollment. * Free from severe organic diseases, including cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, psychiatric disorders, and nervous system diseases. * Free from severe sleep disorder subtypes, such as obstructive sleep apnea syndrome. * No history of allergy to the ingredients and excipients of the test product, and voluntarily sign the informed consent form.
Exclusion criteria
* Aged under 18 years or over 60 years. * Current smokers, or subjects with alcohol drinking habits of ≥3 times per week who have not quit alcohol within one month before the trial. * Long-term intake of stimulating beverages, defined as drinking strong tea, coffee or energy drinks ≥3 cups per day. * Experienced drastic changes in diet or daily routine within one month before enrollment, such as frequent business trips, travel, shift work, or dramatic dietary habit changes. * Diagnosed with severe sleep disorders or obstructive sleep apnea syndrome. * Participated in other human clinical trials, received professional sleep intervention therapy, or consumed products containing N-acetylneuraminic acid within one month before enrollment. * Pregnant or lactating females, or those planning to become pregnant within one year. * Long-term shift workers, regular severe night owls, or subjects with extremely unstable sleeping environments. * Intolerant to wearing smart wearable bracelets or unable to cooperate with trial-related examinations and sample collection. * Staff of the trial institution and other personnel involved in this project. * Scheduled to receive surgical treatment during the trial period. * With a history of severe food or drug allergies. * Diagnosed with digestive system organic lesions such as gastrointestinal ulcers and bleeding. * Suffering from severe physical and mental illnesses under treatment, severe cardiovascular, cerebrovascular and hematological diseases, severe liver and kidney dysfunction, pulmonary infection or malignant tumors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Total Score | Baseline and Day 28 | The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire evaluating sleep quality over the past month, covering 7 domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is scored 0-3, with a total score ranging from 0 to 21; higher scores indicate worse sleep quality. The total PSQI score will be assessed to evaluate changes in participants' sleep status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Scale-14 (FS-14) Total Fatigue Score | Baseline (Day 0) and Day 28 | The Fatigue Scale-14 (FS-14) is a validated self-reported questionnaire developed to assess the severity of subjective fatigue over the past week. It contains 14 binary yes/no items divided into two subscales: 8 items for physical fatigue and 6 items for mental fatigue. Each item is scored 0 (no) or 1 (yes), with a total score ranging from 0 to 14. Higher total scores indicate more severe physical and mental fatigue. The FS-14 total score will be measured to evaluate changes in participants' fatigue status throughout the trial. |
| Spiegel Sleep Questionnaire Total Score | Baseline (Day 0) and Day 28 | The Spiegel Sleep Questionnaire is a validated self-reported scale for evaluating subjective insomnia and sleep status. It contains 6 domains: sleep onset latency, total sleep duration, frequency of nocturnal awakenings, sleep depth, nighttime dream frequency, and morning refreshment feeling. Each item is scored on a 5-level scale of 0, 1, 3, 5, 7 points; the total score ranges from 0 to 42. Higher total scores indicate more severe sleep disturbance. A total score ≥12 suggests clinically meaningful insomnia. The total Spiegel score will be assessed to evaluate the improvement of participants' sleep conditions throughout the trial. |
| Change in Objective Total Sleep Time | Baseline (Day 0) through Day 28 (daily monitoring) | Objective total sleep time (unit: minutes) captured daily by wearable sleep monitoring bracelet from Day 0 to Day 28. The change relative to baseline (Day 0) will be analyzed and reported. |
| Salivary melatonin | Pre-intervention: Day 0 and Day 1; Post-intervention: Day 27 and Day 28. Three sampling time points within 2 hours before bedtime on each collection day. | Salivary melatonin is measured to assess circadian rhythm function, with samples collected at 3 time points within 2 hours before bedtime on D0/D1 (pre-intervention) and D27/D28 (post-intervention). Melatonin AUCg and slope will be calculated to analyze secretion changes after 28-day intervention. |
| Salivary cortisol | Day 0, Day 1, Day 27, Day 28; four serial sampling points within 45 minutes upon waking each collection day. | Salivary cortisol is tested to assess the cortisol awakening response (CAR) and HPA axis activity, which reflects stress status related to sleep disturbance. Saliva samples are collected on pre-intervention Day 0, Day 1 and post-intervention Day 27, Day 28. On each collection morning, four sequential samples are obtained immediately after waking (T0), 15 min (T1), 30 min (T2) and 45 min (T3) after awakening while participants stay supine. Derived parameters including total cortisol awakening AUCg, incremental AUCi, awakening slope and maximum concentration change (Δmax) are calculated to compare HPA axis reactivity before and after the 28-day functional food intervention. All sampling operations follow standardized saliva collection specifications to avoid confounding factors such as food, exercise and oral care products. |
| Change in Objective Sleep Efficiency | Baseline (Day 0) through Day 28 (daily monitoring) | Objective sleep efficiency (unit: percentage, %) captured daily by wearable sleep monitoring bracelet from Day 0 to Day 28. The change relative to baseline (Day 0) will be analyzed and reported. |
| Change in Objective Deep Sleep Duration | Baseline (Day 0) through Day 28 (daily monitoring) | Objective deep sleep duration (unit: minutes) captured daily by wearable sleep monitoring bracelet from Day 0 to Day 28. The change relative to baseline (Day 0) will be analyzed and reported. |
| Change in Objective Sleep Onset Latency | Baseline (Day 0) through Day 28 (daily monitoring) | Objective sleep onset latency (unit: minutes) captured daily by wearable sleep monitoring bracelet from Day 0 to Day 28. The change relative to baseline (Day 0) will be analyzed and reported. |
| Change in Actual Bedtime Recorded via Daily Sleep Diary | Baseline (Day 0) through Day 28 (daily self-report sleep diary) | Participants fill out sleep diaries every day during the 28-day intervention to record actual bedtime. Data collected daily from Day 0 to Day 28 will be analyzed, and the change relative to baseline (Day 0) will be reported. |
| Change in Wake-up Time Recorded via Daily Sleep Diary | Baseline (Day 0) through Day 28 (daily self-report sleep diary) | Participants fill out sleep diaries every day during the 28-day intervention to record wake-up time. Data collected daily from Day 0 to Day 28 will be analyzed, and the change relative to baseline (Day 0) will be reported. |
| Change in Perceived Sleep Quality from Daily Sleep Diary | Baseline (Day 0) through Day 28 (daily self-report sleep diary) | Subjects self-rate daily perceived sleep quality in sleep diaries throughout Day 0 to Day 28. Changes versus baseline (Day 0) will be summarized and reported. |
| Change in Number of Nighttime Awakenings Recorded via Daily Sleep Diary | Baseline (Day 0) through Day 28 (daily self-report sleep diary) | Participants record the daily count of nighttime awakenings in sleep diaries from Day 0 to Day 28. Changes relative to baseline will be reported. |
| Frequency of Daily Sleep-related Discomfort Recorded via Sleep Diary | Baseline (Day 0) through Day 28 (daily self-report sleep diary) | Subjects document any sleep-related discomfort each day in sleep diaries over the 28-day intervention period. The frequency of discomfort will be summarized and reported. |
Contacts
CONTACTYingzhi N/A Chen
Outcome results
None listed