NCT04421339已完成不适用
Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年1月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified HD mutation carriers.
- •Patients who report sleep disturbance as measured by a score ≥5 on the Pittsburgh Sleep Quality Index (PSQI);
- •Stable concomitant medication (no change of medication during last 30 days prior to inclusion);
- •Written informed consent by prospective study participant before conduct of any trial-related procedure;
- •Participant must be able to make an informed decision of whether or not to participate in the study.
排除标准
- •Pregnant or nursing women;
- •Woman of childbearing potential, not using highly effective methods of contraception such as oral, topical or injected contraception, intrauterine device (IUD), contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral tubal ligation) or not at least one year post menopausal;
- •Presence of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus);
- •Use of benzodiazepines, sedating antidepressants (mirtazapine or trazodone) or sedating antipsychotics (olanzapine and quetiapine) in the previous four weeks;
- •Severe cognitive disorders defined as a score < 18 on the MOCA;
- •Participation in another investigative drug trial within 2 months;
- •Subjects who are unlikely to be compliant and attend scheduled clinic visits as required as determined by the Investigator.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Melatonin
Experimental
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, week 5, week 9
The PSQI is a 9-question instrument used to measure the quality and patterns of sleep in adults. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.
次要结局
- Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire(Baseline, week 5, week 9)
- Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)(Baseline, week 5, week 9)
- Improvement in self-perceived cognitive function, as assessed by the Quality of Life in Neurological Disorders questionnaire (NeuroQOLv2.0) Cognition Function - Short Form(Baseline, week 5, week 9)
- Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)(Baseline, week 5, week 9)
- Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)(Baseline, week 5, week 9)
研究者
Erin Furr Stimming
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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