The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
研究概览
简要总结
This study will test whether measuring the circadian clock during treatment of delayed sleep-wake phase disorder results in greater improvements in sleep compared to estimating the circadian clock.
详细描述
The study is a randomized, controlled, parallel double-blind 4-week trial of 0.5 mgs of exogenous melatonin timed to either 3 h before actual dim light melatonin onset (DLMO) based on in-home measurement (M-DLMO, n = 25) or 3 h before DLMO estimated at 2 h before average sleep onset time based on actigraphy and sleep diary (E-DLMO, n = 25) in adult participants with delayed sleep-wake phase disorder. All participants will receive melatonin 0.5 mgs. Outcomes include change in DLMO, subjective and objective sleep parameters, and daytime symptoms.
As of January 7, 2020, the Insomnia Severity Index was removed from the IRB-approved protocol. No data were collected for this measure.
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
- Double (Participant, Care Provider)
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
- •Meet diagnostic criteria for delayed sleep wake phase disorder
- •Female participants of childbearing potential must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed.
排除标准
- •Hypersensitivity to melatonin or any other component of the product
- •Sleep disorder other than delayed sleep wake phase disorder
- •Medical and psychiatric conditions that may influence sleep or be affected by melatonin
- •Current use of medications which may have interactions with melatonin
- •Pregnancy or breastfeeding
- •Routine night shift work
- •Past month travel or planned travel during the study across more than one time zone
- •Use of melatonin in the past month
- •Current use of medications that may interfere with the measurement of melatonin
研究组 & 干预措施
Estimated DLMO
Four weeks (28 days) of nightly melatonin 0.5 mg fast dissolve tablets timed to be administered 3 hours before estimated dim light melatonin onset.
干预措施: Melatonin 0.5 MG (Drug)
Measured DLMO
Four weeks (28 days) of nightly melatonin 0.5 mg fast dissolve tablets timed to be administered 3 hours before measured dim light melatonin onset.
干预措施: Melatonin 0.5 MG (Drug)
Measured DLMO
Four weeks (28 days) of nightly melatonin 0.5 mg fast dissolve tablets timed to be administered 3 hours before measured dim light melatonin onset.
干预措施: Dim Light Melatonin Onset (salivary) (Other)
结局指标
主要结局
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
时间窗: After 4 weeks of melatonin therapy
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin.
次要结局
- Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on Sheehan Disability Scale at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks(After 4 weeks of melatonin therapy)
- Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks(After 4 weeks of melatonin therapy)
研究者
Leslie Swanson
Clinical Associate Professor
University of Michigan