Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - time in bed (TIB)
研究概览
简要总结
The proposed study will include a longitudinal ecological study (Study 1) and a randomised controlled trial (Study 2). The aims will be to (1) identify the sleep-wake profiles in individuals with Major Depressive Disorder (MDD) through clustering; (2) examine the associations between sleep-wake features/profiles and the prognosis of MDD; and (3) investigate the anti-depressant effects of sleep- and circadian-targeted intervention in those with MDD and whether sleep-wake features/profiles may moderate the treatment outcomes.
In Study 1, a total of 140 participants comprising 70 participants with MDD and 70 age- and gender-matched healthy controls will be recruited. Sleep-wake patterns will be collected for 4 consecutive weeks using actigraphy devices and one-off self-report measures will be collected via an in-house smartphone application, PsyHub.
Study 1 and 2 will follow the CONSORT and STROBE guidelines, respectively. The current registration is only for Study 1 of the current research project.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - time in bed (TIB)
时间窗: 24-hour wear time for 4 consecutive weeks
Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TIB is one of the sleep parameters which will be measured by Actigraphy.
Variability in sleep-wake variables using extended cosinor approach - down-mesor
时间窗: 24-hour wear time for 4 consecutive weeks
Rhythm timing (down-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the time of activity offset.
Variability in sleep-wake variables using extended cosinor approach - pseudo F-statistic
时间窗: 24-hour wear time for 4 consecutive weeks
Rhythm robustness (pseudo F-statistic) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the goodness of extended cosine fit.
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: 1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1
A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression, by scoring each item from "0" (not at all) to "3" (nearly everyday), total severity scale ranging from 0 to 27.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - total sleep time (TST)
时间窗: 24-hour wear time for 4 consecutive weeks
Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TST is one of the sleep parameters which will be measured by Actigraphy.
Variability in sleep-wake variables using non-parametric approach - relative amplitude (RA)
时间窗: 24-hour wear time for 4 consecutive weeks
RA is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using non-parametric approach - interdaily stability (IS)
时间窗: 24-hour wear time for 4 consecutive weeks
IS is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using extended cosinor approach - mesor
时间窗: 24-hour wear time for 4 consecutive weeks
Rhythm height (mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the 24-hour adjusted mean rhythm activity,
Variability in sleep-wake variables using extended cosinor approach - acrophase
时间窗: 24-hour wear time for 4 consecutive weeks
Rhythm timing (acrophase) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the time of peak rhythm activity.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep onset latency (SOL)
时间窗: 24-hour wear time for 4 consecutive weeks
Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SOL is one of the sleep parameters which will be measured by Actigraphy.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - wake after sleep onset (WASO)
时间窗: 24-hour wear time for 4 consecutive weeks
Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, WASO is one of the sleep parameters which will be measured by Actigraphy.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep efficiency (SE)
时间窗: 24-hour wear time for 4 consecutive weeks
Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SE is one of the sleep parameters which will be measured by Actigraphy.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - number of awakenings (NOA)
时间窗: 24-hour wear time for 4 consecutive weeks
Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, NOA is one of the sleep parameters which will be measured by Actigraphy.
Variability in sleep-wake variables using non-parametric approach - the least active 5 hours (L5)
时间窗: 24-hour wear time for 4 consecutive weeks
L5 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using extended cosinor approach - amplitude
时间窗: 24-hour wear time for 4 consecutive weeks
Rhythm height (amplitude) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the difference between the peak and nadir of the rhythm.
Variability in sleep-wake variables using extended cosinor approach - up-mesor
时间窗: 24-hour wear time for 4 consecutive weeks
Rhythm timing (up-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the activity initiation time.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - fragmentation index (FI)
时间窗: 24-hour wear time for 4 consecutive weeks
Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, FI is one of the sleep parameters which will be measured by Actigraphy.
Variability in sleep-wake variables using non-parametric approach - intradaily variability (IV)
时间窗: 24-hour wear time for 4 consecutive weeks
IV is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using non-parametric approach - the most active 10 hours (M10)
时间窗: 24-hour wear time for 4 consecutive weeks
M10 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using extended cosinor approach - alpha
时间窗: 24-hour wear time for 4 consecutive weeks
Rhythm shape (alpha) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the width of the rhythm.
Variability in sleep-wake variables using extended cosinor approach - beta
时间窗: 24-hour wear time for 4 consecutive weeks
Rhythm shape (beta) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the steepness of the fitted curve.
次要结局
- Change in Multidimensional Fatigue Inventory (MFI)(1 at baseline, and 1 at the end of study 1)
- Change in Insomnia Severity Index (ISI)(1 at baseline, and 1 at the end of study 1)
- Change in Sheehan Disability Scale (SDS)(1 at baseline, and 1 at the end of study 1)
- Change in Core Consensus Standardized Sleep Diary(4-week daily survey)
- Change in Short Form (6-Dimension) Health Survey (SF-6D)(1 at baseline, and 1 at the end of study 1)
- Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)(1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1)
- Change in Hospital Anxiety and Depression Scale (HADS)(1 at baseline, and 1 at the end of study 1)
研究者
Fiona YY Ho
Associate Professor
Chinese University of Hong Kong