Insomnia disorders with and without circadian dysrhythmia
Conditions
Interventions
Observation group 1(Insomnia Disorder Cohort without Circadian Rhythm Sleep-Wake Disorders):None
Observation group 2(Insomnia Disorder Cohort with Circadian Rhythm Sleep-Wake Disorders):None
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form; 2.Aged >=18 years, regardless of gender; 3.Meet the ICSD-3-TR diagnostic criteria for chronic insomnia disorder; 4.Baseline ISI score >= 8; 5.Patients requiring treatment with lemborexant and sleep hygiene education, as determined by the treating physician;
Exclusion criteria
Exclusion criteria: 1.Diagnosed and unresolved other sleep disorders, psychiatric disorders, or substance use disorders; 2.Presence of serious and unresolved physical (somatic) diseases; 3.Current use of sleep-wake affecting medications/treatments (e.g., hypnotics, CBT-I, sedative antidepressants, melatonin, stimulants) that cannot be discontinued; 4.PHQ-9 score >= 20 or GAD-7 score >= 15; 5.Subjects with suicide risk, suicidal ideation/behavior, or a history of suicide; 6.Shift workers, permanent night workers, or frequent transmeridian travelers (e.g., airline crew); 7.Contraindications to lemborexant per its package insert (e.g., narcolepsy, severe hepatic impairment, pregnant/breastfeeding/planning pregnancy women); 8.Unable to understand/comply with study instructions/protocol or complete online questionnaires (investigator’s judgment); 9.Other conditions deemed unsuitable by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with an ISI score < 8 after 4 weeks of LEM treatment (i.e., the remission rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in gut microbiota and inflammatory factors after 4 weeks of LEM treatment;Proportion of participants with improved circadian rhythm disturbance symptoms based on structured interview after 4 weeks of LEM treatment;Change from baseline in ISI scores for LEM at 5 mg and 10 mg doses;Change from baseline in sleep onset time, sleep efficiency (SE), sleep latency (SL), total sleep time (TST), and wake after sleep onset (WASO) after 4 weeks of LEM treatment;Change from baseline in GAD-7 scores after 4 weeks of LEM treatment;Change from baseline in ISI scores after 1, 2, and 4 weeks of LEM treatment;Change from baseline in ESS scores after 1, 2, and 4 weeks of LEM treatment;ISI response rate at Week 1, Week 2 and Week 4 of LEM treatment; response is defined as a =50% reduction in ISI score from baseline.;Change from baseline in ISI scores for LEM in patients aged 18–55 years and those over 55 years;Change from baseline in PHQ-9 scores after 4 weeks of LEM treatment;Change from baseline in Circadian Function Index, Relative Amplitude, Inter-daily Variability, Intra-daily Stability, and standard deviation of sleep duration and midpoint after 4 weeks of treatment;Between-cohort difference in the proportion of participants with ISI score < 8 after 4 weeks of LEM treatment;Change from baseline in BRIAN scores after 1, 2, and 4 weeks of LEM treatment; | — |
Countries
China
Contacts
Public ContactBin Zhang
Southern Medical University Southern Hospital
Outcome results
None listed