Chronic insomnia disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Possession of a valid nursing license; 2. Currently engaged in full-time nursing work; 3. Insomnia group: Diagnosed with chronic insomnia according to ICSD-3 (Experiencing one or more of the following disturbances: difficulty falling asleep, difficulty staying asleep, early awakening. Difficulty falling asleep is defined as a sleep latency of >=30 minutes, and difficulty staying asleep is defined as waking up after falling asleep and staying awake for =30 minutes); 4. Non-insomnia group: Not diagnosed with chronic insomnia according to ICSD-3; 5. Currently engaged in night shift work and the duty will maintain during the study (averaging at least three night shifts per month, where a night shift involves working at least three hours between 0:00 and 6:00);
Exclusion criteria
Exclusion criteria: 1. Currently diagnosed with physical diseases, including tumors, cerebrovascular diseases, respiratory diseases, cardiovascular diseases, endocrine and metabolic disorders, other chronic inflammatory diseases, or bacterial, fungal, or viral infections in any part of the body; 2. Currently or previously diagnosed with mental illnesses, such as depression, anxiety disorders, schizophrenia, and bipolar disorder; 3. Breastfeeding, pregnant, or planning to become pregnant during the study period; 4. Allergic to the intervention reagents or placebo components used in the study; 5. Use of sleep-related medications within one month before recruitment; 6. Use of systematic antibiotics, antifungal medications within three months, or probiotic supplements within one month before recruitment; 7. Participating in any trial or dietary intervention program currently or within one month before recruitment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of insomnia;The diversity, composition and abundance of gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| sleep quality;Non-targeted metabolomics analysis of faeces;Targeted detection of urinary creatinine;Targeted detection of urinary melatonin metabolite aMT6s; | — |
Countries
China
Contacts
Hunan Provincial People's Hospital