NCT05402761 Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
| NCT ID | NCT05402761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Medical University |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 93 participants |
| Start Date | 2022-08-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 93 participants in total. It began in 2022-08-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
nsomnia is a frequent complaint reported by patients with TBI, and exacerbates their ability to return to productive activity, which subsequently elevate related healthcare costs and burden. Existing literatures found that effects of CBTi, first-line therapy for insomnia, on post-traumatic insomnia is still debated, indicating that developing an alternative nonpharmacological therapy for alleviating insomnia following TBI is required. Besides, digital health is one of strategies to achieve precision health. Thus far, knowledge regarding whether mobile-delivered BBTi has non-inferiority effects as BBTi in treating insomnia is still lacking. Therefore, a RCT with a large sample size to examine the immediate and lasting effects of BBTi and mobile-delivered BBTi on insomnia, mood disturbances, and cognitive dysfunctions in patients following TBI at the recovery stage compared with the control participants.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05402761 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05402761 currently recruiting?
Yes, NCT05402761 is actively recruiting participants. Contact the research team at hychiu0315@tmu.edu.tw for enrollment information.
Where is the NCT05402761 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT05402761 clinical trial?
NCT05402761 is sponsored by Taipei Medical University. The trial plans to enroll 93 participants.
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