Patients with maintenance hemodialysis insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for end-stage renal disease (ESRD) and regularly receive maintenance hemodialysis (MHD) for at least 3 months, 2-3 times per week, with each session lasting 3-5 hours; 2.Have insomnia, defined as a score of >=10 on the Insomnia Severity Index (ISI).
Exclusion criteria
Exclusion criteria: 1. Patients with potential comorbid sleep disorders, including obstructive sleep apnea syndrome (STOP Bang score >=5), positive screening for Restless Legs Syndrome (International Restless Legs Scale [IRLS] score >=16), parasomnias (confirmed by detailed medical history), or circadian rhythm sleep-wake disorders (confirmed by detailed medical history); 2. Patients with severe complications, such as recent myocardial infarction (within 6 months), New York Heart Association (NYHA) Functional Classification Class III-IV, malignant tumors, acute heart failure, severe infections, severe anemia (hemoglobin [Hb] 160/100 mmHg); 3. Patients who are unable to sign informed consent or complete the intervention for any reason (e.g., with severe mental illness or cognitive impairment; cannot fully understand the content of the instruments or intervention or unwilling to participate); 4. Shiftworkers; 5. Severe depressive symptoms (Patient Health Questionnaire-9 >= 20).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate;Enrollment rate;Adherence;Report completeness;Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia symptom;Sleep parameters; | — |
Countries
China
Contacts
Shu Guang Hospital affiliated to Shanghai TCM College