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Repetitive transcranial magnetic stimulation compared with cognitive behavioral therapy for the treatment of insomnia in cancer survivors: a non-inferiority randomized controlled trial

Repetitive transcranial magnetic stimulation compared with cognitive behavioral therapy for the treatment of insomnia in cancer survivors: a non-inferiority randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048095
Enrollment
Unknown
Registered
2021-06-30
Start date
2021-06-22
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Cancer insomnia

Interventions

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Cancer patients; 2. Han nationality; 3. Aged 30 to 65 years old, no gender limit; 4. Comply with the DSM-V diagnostic criteria for insomnia disorder and the international classification of sleep disorders (third edition) standards; 5. Subject's Insomnia Severity Index (ISI) >=15 points; 6. The subject signs a written informed consent form, indicating that they understand the purpose and process of the trial and are willing to participate in the trial; 7. There is currently no evidence of cancer recurrence or new tumors; 8. Completed surgery, radiotherapy and/or chemotherapy for at least 3 months.

Exclusion criteria

Exclusion criteria: 1. Those who have participated in other clinical trials within 30 days before screening; 2. People who have previously abused and dependent on alcohol or drugs, as well as those who drink regularly or before going to bed; 3. Those who have taken anti-inflammatory drugs within 30 days before screening or currently suffer from inflammatory diseases; 4. Those who have received transcranial magnetic stimulation (TMS) therapy in the past 3 months; 5. Patients whose transcranial magnetic stimulation therapy is contraindicated; 6. Those who have a history of organic brain diseases or comorbidities, such as Parkinson's patients; 7. People with previous history of sleep apnea (breathing disorder index AHI score>15), COPD, restless legs syndrome, periodic leg movements (cyclical leg movement index > 25); 8. Those who have a history of epilepsy; 9. Consciousness disorder caused by any cause in the 12 months before screening; 10. People with previous schizophrenia and bipolar disorder; 11. Body mass index (BMI) > 35 kg/m2; 12. The physical condition is weak, not enough to complete the test; 13. Unable to participate normally during the research period.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index (ISI);Actigraph;

Countries

China

Contacts

Public ContactLu Lin

Peking University Sixth Hospital

linlu@bjmu.edu.cn+86 10 82805308

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026