Nurse-guided treatment for insomnia in patients recovering from brain injuries
Official title: Effects of Nurse-Guided Brief Behavioral Treatment for Insomnia on Sleep, Mood, and Cognition: Model Establishment and Application in Patients at the Recovery Phase Following Traumatic Brain Injury
Run by Taipei Medical University · NCT05402761 · Data updated 2026-11-12
This study is testing whether a nurse-guided treatment for insomnia can help people recovering from brain injuries sleep better and improve their mood and thinking.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 65 Years |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Taipei Medical University Academic / other |
| Locations | 2 sites (Taipei and 1 other locations) |
| Status | Recruiting |
| Started | August 15, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT05402761 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults diagnosed with TBI at least three months prior, experiencing chronic insomnia, and able to communicate in Mandarin Chinese.
✕Probably not a fit
Patients with pre-existing sleep disorders, psychiatric conditions, or those currently pregnant or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of nurse-guided brief behavioral treatment for insomnia (BBTi) and mobile-delivered BBTi in patients recovering from traumatic brain injury (TBI). The study aims to compare these interventions against a sleep hygiene control group to assess their impact on insomnia, mood disturbances, and cognitive dysfunctions. A total of 228 participants will be randomly assigned to one of three groups over a three-year period, with assessments conducted by blinded evaluators. The goal is to establish a non-pharmacological approach to managing insomnia in TBI survivors.
Why it matters
Potential benefit: If successful, this study could provide a new, effective non-pharmacological treatment option for insomnia in patients recovering from traumatic brain injury.
How similar studies have gone: While the approach of using BBTi is relatively novel in this context, existing literature suggests that non-pharmacological interventions for insomnia have shown promise in other populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * have received a diagnosis of TBI at least 3 months before enrollment (TBI in chronic stage), * yield an initial (i.e., rated in the emergency room) GCS score of 3-15 (mild to severe) and have GCS score of 15 when enrolling into the study, * report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months, * have post-TBI insomnia with a total score \> 7 on the Chinese version of the insomnia severity scale (CISI) at screening, * be able to communicate in Mandarin Chinese, and be able to complete cognitive tasks (having Rancho Los Amigos Levels of Cognitive Functioning scale score \> 9) Exclusion Criteria: * include premorbid diagnoses of seizure, * sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score \> 3), * psychiatric diseases, * substance abuse, * alcoholism * Shift workers and women who are pregnant, breastfeeding, or in the menopausal transition
Where it's running
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Taipei Medical University
Taipei, Taiwan Recruiting -
Skin Kong International Health Center
Taipei, Taiwan Recruiting
Study contacts
- Study coordinator: Hsiao-Yean Chiu, Ass. Professor
- Email: hychiu0315@tmu.edu.tw
- Phone: 886-2-27361661
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.