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Sleep restriction therapy for patients on hemodialysis with insomnia: A pilot study

Sleep restriction therapy for patients on hemodialysis with insomnia: A pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120415
Enrollment
Unknown
Registered
2026-03-13
Start date
2026-03-13
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with maintenance hemodialysis insomnia

Interventions

Intervention group:Sleep hygiene education + Sleep Restriction Therapy (SRT). SRT is developed based on the protocol validated by Professor Simon Kyle from the University of Oxford and revised accordi

Sponsors

Shu Guang Hospital affiliated to Shanghai TCM College
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Recruitment rate;Enrollment rate;Adherence;Report completeness;Incidence of adverse events;

Secondary

MeasureTime frame
Insomnia symptom;Sleep parameters;

Countries

China

Contacts

Public ContactXiaowei Pu

Shu Guang Hospital affiliated to Shanghai TCM College

pxwdoris@163.com+86 136 3648 8354

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026