NCT04457440暂停不适用
A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in HbA1C (%)
研究概览
简要总结
The proposed study aims to evaluate if improving sleep could enhance the intensive lifestyle intervention for improving weight loss and glycemic control in prediabetic individuals who have insomnia with short sleep duration. A cognitive behavioral intervention for insomnia with adjustments aimed at increasing sleep duration (CBT-Sleep) will be used for this study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a) Hong Kong residents,
- •(b) BMI > 23kg/m2,
- •(c) aged 18 to 65 year-old,
- •(d) have prediabetes, defined by a plasma fasting glucose concentration of 5.6 to 6.9 mmol/L, impaired glucose tolerance (2hglucose 7.8-11.0 on OGTT), or HbA1c 5.7-6.4%,
- •(e) have average habitual sleep duration < 6.5 hours, confirmed by actigraphy measure of sleep for 2 weeks or have insomnia, confirmed in a clinical sleep interview and actigraph-measure of greater than 30 minutes of sleep onset latency or nighttime awakening for 3 nights or more per week
排除标准
- •(a) have unmanaged sleep apnea or other sleep disorders,
- •(b) have any current severe mental illnesses,
- •(c) have any medical conditions or medication use that could undermine the efficacy of the sleep intervention,
- •(d) have shift work schedules,
- •(e) have any environmental constraints on the feasibility of implementing a sleep schedule of at least 7.5 hours
结局指标
主要结局
Changes in HbA1C (%)
时间窗: 12 weeks from baseline
Changes in fasting glucose concentration (mg/dl)
时间窗: 12 weeks from baseline
Changes in 2-hr oral glucose tolerance (mg/dl)
时间窗: 12 weeks from baseline
次要结局
- Changes in subjective wake after sleep onset(12 weeks from baseline)
- Changes in objective sleep onset latency(12 weeks from baseline)
- Changes in dietary composition(12 weeks from baseline)
- Changes in subjective sleep onset latency(12 weeks from baseline)
- Changes in objective wake after sleep onset(12 weeks from baseline)
- Changes in objective total sleep time(12 weeks from baseline)
- Changes in acceptance of physical activity(12 weeks from baseline)
- Changes in weight loss self efficacy(12 weeks from baseline)
- Changes in insomnia symptom severity(12 weeks from baseline)
- Changes in subjective total sleep time(12 weeks from baseline)
- Changes in body weight (kg)(12 weeks from baseline)
- Changes in psychological distress(12 weeks from baseline)
- Changes in quality of life(12 weeks from baseline)
- Changes in food craving(12 weeks from baseline)
- Changes in weight control strategies(12 weeks from baseline)
研究者
Dr. Chan Wai Sze
Assistant Professor
The University of Hong Kong
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity DisorderNCT00867451Children's Hospital Medical Center, Cincinnati8
Unknown
不适用
A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASDSleepAutism Spectrum DisorderAutismNCT04539990Soroka University Medical Center100
招募中
不适用
Improving Sleep, Decision-Making, and Eating in Adolescents With ObesityAdolescent OverweightAdolescent ObesitySleepEating BehaviorsDietary IntakeNCT06745570Nemours Children's Clinic50
已完成
不适用
Optimizing Sleep Health in NursesCircadian Rhythm Sleep-Wake Disorders, Shift Work TypeSleep Initiation and Maintenance DisordersNCT05965609Oregon State University60
已完成
不适用
A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast CancerSleepBreast CancerNCT02613923Case Comprehensive Cancer Center17