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수면 장애가 있는 환자에게 적용한 디지털 치료기기의 임상적 유효성에 대한 체계적 문헌고찰: 대조군분류에 따른 하위 분석

A Systematic Review on the Clinical Efficacy of Digital Therapeutics for Sleep Disorders: Subgroup Analysis by Control Groups

  • 전효선 (성균관대학교 삼성융합의과학원 의료기기산업학과) ;
  • 강은지 (삼성서울병원 임상역학센터) ;
  • 유수정 (성균관대학교 삼성융합의과학원 의료기기산업학과)
  • Hyosun Jeon (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University) ;
  • Eunjee Kang (Center for Clinical Epidemiology, Samsung Medical Center) ;
  • Soojung Yoo (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University)
  • 투고 : 2023.05.01
  • 심사 : 2023.06.28
  • 발행 : 2023.12.31

초록

Background: The purpose of this systematic review was to investigate the effects of digital therapeutics for insomnia on sleep disorders and mental health improvement compared to the control group. Methods: Following the guidelines on systematic review(PRISMA, NECA), a literature search was conducted through PubMed, Cochrane Library, EMBASE, RISS, KISS, and KoreaMed using keywords. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias and effect size assessment. Results: Thirty eight RCT met criteria for inclusion. When compared against three control conditions, the digital therapeutics for insomnia was an effective intervention for improvement sleep disorders and mental health in comparison to waiting list and Patient-directed care with some intervention by medical staff. However, digital therapeutics for insomnia were no more effective than face-to-face CBT-I control group. Conclusion: The efficacy of digital therapeutics for insomnia was evaluated differently depending on the control group. Therefore, in phase 3 clinical trials for efficacy evaluation, it is necessary to review whether the control group has been properly established.

키워드

참고문헌

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