NCT01209728已完成1 期
A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Simulated driving variables
研究概览
简要总结
This is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. The objectives if this study are primarily: 1. To determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily: 2. To compare simulated driving performance deficits in elderly primary insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least one of the following driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed (speed deviation), lane excursions, and a driving composite score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A patient or subject may participate in the study if, at least, the ALL of the criteria below are met.
- •The participant:
- •Is a male or female of non-childbearing potential and 65 years of age or older at prestudy (screening);
- •Has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months prior to screening;
- •Has a current valid driver's license;
- •Their regular bedtime is between 9 pm (21:00) and 12 am (00:00);
- •During the study, are willing to refrain from napping;
- •Additionally, a primary insomnia patient must meet the following inclusion criteria:
- •Has a diagnosis of Primary Insomnia;
- •Reports total sleep time of < 6 hours on at least 3 out of 7 nights each week during the 4 weeks prior to screening;
- •Reports spending 6 to 9 hours nightly in bed on at least 3 out of 7 nights each week during the 4 weeks prior to screening.
排除标准
- •A patient may not participate in the study if ANY of the criteria below (among others determined by the study staff) apply.
- •The participant:
- •Has visual or auditory impairment;
- •Has a history of clinically significant endocrine (including diabetes), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases;
- •Has a history of neoplastic disease ;
- •Is taking, or plans to take, one or more of the following medications (non-inclusive), within the 2 weeks prior to screening and throughout the course of the study: Centrally acting anticholinergics or antihistamines; Melatonin; Anticonvulsants; Antipsychotics; Anxiolytics; Benzodiazepines; Hypnotics; Any CNS depressants; Over-the-counter medications that could affect sleep; Stimulants; Diet pills; Anti-depressants; Disulfiram;
- •Has a positive screening urine drug test (e.g., positive for benzodiazepines, cannabinoids, cocaine, etc.);
- •Has a lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder or a psychiatric condition requiring treatment with a prohibited medication; or other current psychiatric condition that, in the investigator's opinion, would interfere with the subject/patient's ability to participate in the study ;
- •Has evidence of suicidality;
- •Has a history of transmeridian travel (across > 3 time zones or > 3 hour time difference) within two weeks prior to screening or anticipates transmeridian travel during the study;
- •Has a history of shift work (defined as permanent night shift or rotating day/night shift work) within the past two weeks prior to screening or anticipates need to perform shift work during the study;
- •Has a history or diagnosis of any of following conditions, in the opinion of the investigator: Narcolepsy; Cataplexy (familial or idiopathic); Circadian Rhythm Sleep Disorder; Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder; Sleep-related Breathing Disorder (obstructive or central sleep apnea syndrome, central alveolar hypoventilation syndrome); Periodic Limb Movement Disorder; Restless Legs Syndrome; Primary Hypersomia; Excessive Daytime Sleepiness (EDS), not attributable to Primary Insomnia
- •Has a recent and/or active history of a confounding neurological disorder, including but not limited to: seizure disorder, stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness and residual impairment within the last 10 years;
- •Has a history of allergy, exceptional sensitivity, or adverse reaction to alcohol;
- •Has a significant history of motion sickness or demonstrates significant simulator sickness during practice drives at screening;
- •Consumes excessive amounts of alcohol or subject or patient consumes alcohol to promote sleep (i.e., within 3 hours before going to bed);
- •Has never consumed alcohol;
- •Consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages.
研究组 & 干预措施
Primary insomnia patients and healthy subjects
Experimental
Elderly participants, including primary insomnia patients and healthy subjects
干预措施: Placebo/ethanol (blinded) (Other)
结局指标
主要结局
Simulated driving variables
时间窗: Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day.
Simulated driving variables which may include (standard deviation of lane position (SDLP), speed deviation, lane excursions, or a composite score of several driving variables).
次要结局
未报告次要终点
研究者
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