Status:
RECRUITING
Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
Lead Sponsor:
Taipei Medical University
Conditions:
Insomnia
Traumatic Brain Injury
Eligibility:
All Genders
20-65 years
Phase:
NA
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 ...
Detailed Description
Background: Insomnia is highly prevalent in adults with traumatic brain injury (TBI), which in turn undermine their mood, cognitive functions, and quality of life. However, an effective non-pharmacolo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05402761
Start Date
August 15 2022
End Date
December 1 2026
Last Update
August 15 2025
Active Locations (2)
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1
Taipei Medical University
Taipei, Taiwan, 110
2
Skin Kong International Health Center
Taipei, Taiwan, 111