NCT07266415进行中（未招募）不适用
A 2-Week, Single-Center, Double-blind, Exploratory Study to Evaluate the Safety and Efficacy of the Sleep Inducing Digital Sound Application on Pregnant Women in Their 1st and 2nd Trimester With Insomnia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome measurement
研究概览
简要总结
This study aims to evaluate the safety and efficacy of sleep inducing digital sound application on pregnant women in their 1st and 2nd trimester with insomnia
详细描述
Duration of study period (per participant): Screening period (0-1 week), Intervention period (2 weeks), Follow-up period (1 week, without digital application use). Patient needs to visit the site at least 1 time (Screening). Other procedures will be conducted online. First visit is before the screening period, mainly to on-board patients and to train patients for accurate usage of the digital application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •19 years older
- •pregnant women in their 1st and 2nd trimester
- •suffering from insomnia symptom
- •scored 10 or high in screening ISI
- •a person who voluntarily agreed to participate in this RCT
排除标准
- •Has a confirmed diagnosis of insomnia disorder other than chronic insomnia based on DSM-5(ex. Narcolepsy, Periodic Limb Movement, Restless Leg syndrome, etc)
- •Has a confirmed diagnosis of other neuropsychiatric disease
- •Has an history of suicidal ideat or attempt
- •Shift worker
- •Going through other interventions regarding insomnia(sleeping pills, light therapy, other alternative interventions)
- •Has a severe auditory, visual, or cognitive impairment
- •A person who cannot familiarize with the usage of smartphones and digital applications
- •Has a history of alcohol or other substance use disorder
- •A person with high risk pregnancy considered inadequate to participate in this trial by obstetric experts
- •A person considered inadequate to participate in this trial by a clinical expert
结局指标
主要结局
Primary outcome measurement
时间窗: 1 week
Insomnia severity index
次要结局
- Sleep Latency (SL, Minutes), assessed using a sleep diary(1 week)
- Sleep Latency (SL, Minutes), assessed using a smartwatch(1 week)
- Sleep Efficiency (SE, Percentage), assessed using a sleep diary(1 week)
- Sleep Efficiency (SE, Percentage), assessed using a smartwatch(1 week)
- Wake After Sleep Onset (WASO, Minutes), assessed using a sleep diary(1 week)
- Wake After Sleep Onset (WASO, Minutes), assessed using a smartwatch(1 week)
- Total Sleep Time (TST, Minutes), assessed using a sleep diary(1 week)
- Total Sleep Time (TST, Minutes), assessed using a smartwatch(1 week)
- Sleep Quality (SQ, Score 1-10; bad-good), assessed using a sleep diary(1 week)
- Pittsburgh Sleep Quality Index (PSQI, Score 0-21; better-worse)(2 weeks)
- Edinburgh Postnatal Depression Scale (EPDS, Score 0-30; better-worse)(2 weeks)
- Generalized Anxiety Disorder-7 (GAD-7, Score 0-21; better-worse)(2 weeks)
- Pregnancy-Related Anxiety Questionnaire (PRAQ, Score 32-128; better-worse)(2 weeks)
研究者
Jee Yoon Park
Professor
Seoul National University Bundang Hospital
研究点 (1)
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