RecruitingNot Applicable

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

Taiwan93 participantsStarted 2022-08-15

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes in Insomnia Severity

Timeframe: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

Changes in Sleep quality

Timeframe: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

Changes in Daytime Sleepiness

Timeframe: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)

Timeframe: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

Changes in Sleep parameters from sleep logs: after sleep onset(WASO)

Timeframe: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

Changes in Sleep parameters from sleep logs: total sleep time(TST)

Timeframe: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

Changes in Sleep parameters from sleep logs: sleep efficiency(SE)

Trial details

NCT IDNCT05402761

SponsorTaipei Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Hsiao-Yean Chiu, Ass. Professor

886-2-27361661 hychiu0315@tmu.edu.tw

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