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Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026v7
  2. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Dec 2024 to Dec 2026
    v6
  3. Primary completion date: Jun 2024 to Dec 2024v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jun 2023 to Jun 2024
    • Study sites: 1 to 2
    • Start date changed from estimate of Aug 2022 to Aug 15, 2022
    v4
  5. Enrollment target: 228 to 93v3
  6. Start date: Jun 2022 to Aug 2022
    • Study completion date: Dec 2023 to Dec 2024
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05402761
Lead Sponsor Taipei Medical University
Conditions
(from sponsor)		 Insomnia, Traumatic Brain Injury
Related terms Brain Injuries, Traumatic, Sleep Initiation and Maintenance Disorders
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov