| 摘要: | 目的：我們進行了一系列研究：1) 檢查失眠與中風後認知障礙風險之間的縱向關聯（研究 1）； 2) 翻譯和驗證印度尼西亞語版本的中風患者睡眠狀況指標 (ISCI)（研究 2）； 3）同時檢驗幾種失眠數字認知行為療法（CBTI）方法對主觀睡眠參數的影響，如總睡眠時間（TST）、入睡潛伏期（SOL）、入睡後醒來（WASO）、睡眠效率 (SE)，和失眠症狀（研究 3）； 4) 檢查護士主導的面對面簡短失眠行為療法 (BBTI) 和基於網絡的 BBTI 相對於睡眠衛生教育 (SHE) 對中風倖存者失眠症狀的影響（研究 4）。
方法：研究 1 是一項多中心、以醫院為基礎的回顧性隊列研究，隨訪期為 13 年（2004-2017 年），其中包括患有中風的成年參與者（n = 1,775）。 Cox 比例風險回歸模型用於確定卒中伴失眠與非失眠之間的無認知障礙生存率差異。 研究 2 是一項方法學研究。 總共從中風康復門診招募了 160 名中風倖存者。 首先，使用傳統的翻譯過程將英文版的睡眠狀況指標 (SCI) 翻譯成 ISCI。 在第二階段，檢查了心理測量屬性，包括 ISCI 的有效性和可靠性。 使用接受者操作特徵（ROC）分析。 研究 3 是一項系統回顧和網絡薈萃分析。 從開始到 2020 年 6 月 27 日，我們搜索了四個電子數據庫。我們納入了隨機對照試驗 (RCT)，比較數字 CBTI 方法（即基於網絡、基於電話或基於移動的失眠認知行為療法）與主動或非主動 控制。 使用常客框架中的隨機效應網絡薈萃分析來估計治療效果。 主要結果是自我報告的 TST、SOL、WASO、SE 和失眠嚴重程度，使用睡眠日誌或有效問捲進行測量。
研究 4 是一項評估員設盲的試驗性三臂平行隨機對照試驗。 所有數據均使用紙質問卷從印度尼西亞門診的 30 名中風主訴失眠患者中收集。
結果：研究 1 在隨訪期間，1,775 名中風患者中有 75 名出現認知障礙。 因此，在隨訪期間，146 名失眠中風患者中有 20 名和 1,629 名無失眠中風患者中有 55 名出現認知障礙。 與沒有失眠的中風隊列相比，有失眠的中風隊列有更高的認知障礙風險（調整後的風險比 = 2.38；95% 置信區間 = 1.41–4.03）。 ISCI 研究 2 的 Cronbach α 係數為 0.89，重測信度為 0.78。 驗證性因素分析顯示 ISCI 提供了令人滿意的模型擬合。 ISCI 與失眠嚴重程度指數-印度尼西亞版本相關（r = ?0.81，p < 0.001）。 此外，ISCI 與印度尼西亞版的廣泛性焦慮症 7 項和患者健康問卷 9 項相關（r = ?0.32 和 ?0.52，分別為 p <0.001）。 ROC 測試表明，< 23 的截止點產生最大的靈敏度 (0.94) 和特異性 (0.97)，受試者工作特徵曲線下的面積為 0.96。 研究 3 包含 11,315 名參與者的 54 項隨機對照試驗，平均年齡為 45.31 歲。 與其他睡眠促進療法相比，基於網絡的 CBTI 引導顯著延長了 TST（範圍從 17.85 到 42.80 分鐘），縮短了 SOL（範圍從 -18.76 到 – 27.67 分鐘），降低了 WASO（範圍從 -11.40 到 -42.80 分鐘）， 並增加了 SE（從 2.90% 到 12.27%）。 累積排名曲線下的表面表明，基於 Web 的 CBTI 指導最有可能排名最佳。 研究 4 三十名患者被隨機分配到基於網絡的 BBTI、面對面的 BBTI 和 SHE。 與 SHE 相比，基於 Web 的 BBTI 以及面對面的 BBTI 減輕了失眠的嚴重程度。 此外，與 SHE 相比，面對面的 BBTI 和基於網絡的 BBTI 在緩解焦慮、抑鬱和疲勞方面具有相當的效果。
結論：系列研究表明，經歷失眠的中風倖存者隨著時間的推移表現出認知障礙的風險增加。 8 項 ISCI 被發現是有效和可靠的。 與其他數字睡眠促進方案相比，基於網絡的 CBTI 指導顯示出更大的睡眠改善。 與面對面的 BBTI 相比，基於網絡的 BBTI 在緩解失眠方面產生了非劣效。
Purposes: We conducted a series of studies: 1) to examine the longitudinal association between insomnia and the risk of cognitive impairment following stroke (Study 1); 2) to translate and validate the Indonesian version of the Sleep Condition Indicator (ISCI) for people with stroke (Study 2); 3) to simultaneously examine the effects of several digital cognitive behavior therapy for insomnia (CBTI) methods on subjective sleep parameters, such as total sleep time (TST), sleep onset latency (SOL), waking after sleep onset (WASO), sleep efficiency (SE), and insomnia symptoms (Study 3); and 4) to examine the effects of nurse-led face-to-face brief behavior therapy for insomnia (BBTI) and web-based BBTI relative to sleep hygiene education (SHE) on insomnia symptoms in stroke survivors (Study 4).
Methods: Study 1 was a multicenter, hospital-based retrospective cohort study with a 13-year follow-up period (2004–2017) included adult participants with stroke (n = 1,775). A Cox proportional-hazards regression model was used to determine the differences in cognitive impairment-free survival between stroke with insomnia and without insomnia. Study 2 was a methodology study. A total of 160 stroke survivors were recruited from stroke rehabilitation outpatient clinics. First, a conventional translation process was used for translating the English version of the Sleep Condition Indicator (SCI) into ISCI. In the second stage, the psychometric properties were examined, including the ISCI's validity and reliability. A receiver operating characteristics (ROC) analysis were used. Study 3 was a systematic review and network meta-analysis. Four electronic databases were searched from inception to June 27, 2020. We included randomized control trials (RCTs) comparing digital CBTI approaches (i.e., web-based, telephone-based, or mobile-based cognitive behavioral therapy for insomnia) with active or inactive controls. A random effect network meta-analysis in a frequentist framework was used for estimating treatment effects. The primary outcomes were self-reported TST, SOL, WASO, SE, and insomnia severity, measured using sleep logs or valid questionnaires.
Study 4 was an assessor-blinded, a pilot three-arm, parallel RCT. All data were collected by using paper-based questionnaire from 30 patients with stroke complaining insomnia in outpatient clinic in Indonesia.
Results: Study 1 Over the course of the follow-up period, 75 of the 1,775 stroke patients experienced cognitive impairment. Accordingly, cognitive impairment was observed in 20 of 146 stroke patients with insomnia and in 55 of 1,629 stroke patients without insomnia, during the follow-up period. The stroke with insomnia cohort had a higher risk of cognitive impairment compared with the stroke without insomnia cohort (adjusted hazard ratio = 2.38; 95% confidence interval = 1.41–4.03). Study 2 the ISCI had a Cronbach's alpha of 0.89 and test-retest reliability of 0.78. Confirmatory factor analysis revealed that ISCI provided a satisfactory model fit. The ISCI correlated with the Insomnia Severity Index-Indonesian version (r = ?0.81, p < 0.001). Furthermore, the ISCI was associated with Indonesian version of Generalized Anxiety Disorder 7-item, and Patient Health Questionnaire 9-item (r = ?0.32 and ?0.52, both p <0.001 respectively). ROC tests revealed that a cutoff point of < 23 yielded the greatest sensitivity (0.94) and specificity (0.97), with an area under the receiver operating characteristic curve of 0.96. Study 3 54 RCTs comprising 11,315 participants with mean age of 45.31 years were included. Compared to other sleep promotion treatments, guided web-based CBTI significantly prolonged TST (ranging from 17.85 to 42.80 mins), shortened SOL (ranging from ?18.76 to – 27.67 mins), decreased WASO (ranging from ?11.40 to ?42.80 mins), and increased SE (ranging from 2.90% to 12.27%). The surface under the cumulative ranking curve indicated that guided web-based CBTI was most likely to be ranked the best. Study 4 Thirty patients were randomly assigned to web-based BBTI, face-to-face BBTI, and SHE. Web-based BBTI as well as face-to-face BBTI mitigated insomnia severity compare to SHE. Furthermore, face-to-face BBTI and web-based BBTI had comparable effects on relieving the levels of anxiety, depression, and fatigue compared to SHE.
Conclusions: The series studies suggest that stroke survivors experiencing insomnia exhibited an increased risk of cognitive impairment over time. The 8-item ISCI was found to be valid and reliable. In comparison with other digital sleep promotion regimens, guided web-based CBTI showed greater sleep improvements. The web-based BBTI yielded non-inferior effects on insomnia mitigation compared to face-to-face BBTI. |
