The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time in Bed
研究概览
简要总结
This research is being done to evaluate the effects of a sleeping pill (eszopiclone, Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in patients with knee pain.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64
- •Diagnosed with and under physicians care for osteoarthritis of the knee according to American College of Rheumatology Criteria with radiographic evidence demonstrating at least grade 1 osteoarthritis (OA)
- •Report at least typical arthritic pain>4 out of 10 (0=no pain, 10=the most extreme pain imaginable)
- •Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and International Classification of Sleep Disorders, Revised definition (ICSD-R) criteria for either primary (psychophysiologic) insomnia or insomnia secondary to osteoarthritis
- •Insomnia symptoms must include problems with middle of the night awakenings
- •Insomnia symptom duration > 6 months
- •Baseline, 2-week, sleep diary average wake after sleep onset time >30 minutes
- •Baseline self-reported total sleep time < 6.5 hours per night
- •Patients taking NSAID therapy for pain must be on a stable dose for a period of at least one month prior to initiating the study
排除标准
- •Intrinsic sleep disorders other than insomnia (sleep apnea, periodic limb movement disorder, etc)
- •Significant rheumatologic or chronic pain disorders other than osteoarthritis of the knee, including fibromyalgia or the complaint of widespread pain impacting 4 quadrants, complex regional pain syndrome, post herpetic neuralgia, etc)
- •Major medical disease (including, hepatic impairment, chronic obstructive pulmonary disease/compromised respiratory function, cancer, dementia, diabetes, congestive heart failure, cerebrovascular disease, raynaud's syndrome)
- •Active major psychiatric disorders (including dementia or cognitive impairment) and history of schizophrenia or bipolar I disorder
- •History of serious suicide attempt; 6) history of alcohol or substance (including prescription medications) abuse
- •Pregnancy or plans to become pregnant within 6 months
- •Intraarticular steroid injection within the past month
- •Regular (>3 days/week) use of antidepressants, antipsychotics, and mood stabilizers, within the past two months
- •Regular (> 3/week) use of myorelaxants, narcotics, sedative hypnotics, and anticonvulsants within the past one month
- •Unwilling or unable to discontinue all use of the medications listed in #10 for two weeks prior to starting the study
- •Unwilling or unable to discontinue all centrally acting agents and all analgesic usage within 24 hours of pain testing sessions
- •Refusal to provide consent to contact patient's physician to establish diagnosis and obtain medical record information
- •Regular tobacco or nicotine use
- •Heavy caffeine use [(>2 cups of coffee/day (equivalent)
- •History of previous allergic reaction or severe side effects to sedative hypnotics
- •Use of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, troleandomycin, ritonavir, nelfinavir)
- •In addition, subjects will undergo in-laboratory blood tests prior to receiving drug and will be excluded from further participation if they exhibit: a) positive pregnancy test, b) positive toxicology (benzodiazepine, opioids, Tetrahydrocannabinol (THC), alcohol, and stimulants), c) abnormal liver enzyme panel
研究组 & 干预措施
Eszopiclone
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
干预措施: Eszopiclone (Drug)
Placebo
3mg placebo capsule, once daily at bedtime for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Time in Bed
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
Total time in bed, in minutes
Wake After Sleep Onset (WASO)
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
Total minutes of wakefulness recorded after sleep onset. (Recorded in Daily Sleep Diary) WASO= time awake in the middle of the night, not counting SL or time in bed after awakening. Recorded in minutes
Sleep Latency (SL)
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
Sleep Latency: time taken to fall asleep, in minutes (as recorded in daily sleep diary)
Number of Awakenings
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
As recorded in daily sleep diary
Total Sleep Time (TST)
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
minutes spent asleep as recorded in daily sleep diary
Sleep Efficiency (SE)
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
\[(TST/ TIB)X 100\], (%) as recorded in daily sleep diary
Sleep Quality (SQ)
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
As recorded in daily sleep diary. Visual analog scales (VAS) Sleep Quality Ratings 0-100, 0= extremely poor sleep quality, (shallow and unrefreshing) and 100=excellent sleep quality (deep and refreshing)
WASO as Assessed by Actigraphy
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. WASO recorded by device = total minutes of wakefulness after sleep onset, in minutes.
Mean Level of Pain Experienced Throughout the Day
时间窗: Mean of baseline, 6 week follow-up and 12 week follow-up
Assessed using a Daily Pain Diary with a scale 0-100, 0 being no pain, 100 being the most severe/intense
TST as Assessed by Actigraphy
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. TST recorded by device = total minutes spent asleep
Sleep Efficiency as Assessed by Actigraphy
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep efficiency is the index of sleep percentage recorded, equal to total sleep time divided by the time in bed X 100 = X%.
Sleep Latency as Assessed by Actigraphy
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep latency is the time taken to fall asleep, or equal to lights out- sleep onset (sleep onset: time when sleep is first scored after lights out, first scorable epoch).
Insomnia Severity Index (ISI) Mean Total Scores
时间窗: Mean of baseline, 6 week follow-up, and 12 week follow-up
The ISI is made up of 7 questions, each possible of earning a score of 0-4, making the total range 0-28, where 0 indicates no severity/no problem with sleep and therefore no insomnia, or 28, being very severe with the highest level of insomnia
Diffuse Noxious Inhibitory Control (DNIC) Index Scores
时间窗: Mean of baseline, 6 week follow-up and 12 week follow-up
PPTh:a somedic algometer's 1cm2 rubber probe was placed over muscle belly, with pressure increasing steadily at constant rate (30kPA/Sec), until subject indicated that s/he "first felt pain." PPTh ratings were obtained on right brachioradialis \& right trapezius in a random order (average was taken from both areas at each time point). During each cold pressor task, participants immersed contralateral hand (left) up to wrist, in a circulating cold water bath maintained at 4°C. 20 seconds after commencing hand immersion, PPTh was re-assessed on either right brachioradialis or right trapezius (the same site as baseline assessment). After PPTh assessment, participants removed hands from water. DNIC was measured as the % change in PPTh during cold pressor, relative to baseline PPTh \[i.e., (mean PPTh during cold pressor / mean PPTh prior to cold pressor)\*100\]. Increase in PPTh during cold pressor (i.e., percentage scores above 100) reflects normal functioning of pain-inhibitory processes.
Temporal Summation (TS)
时间窗: Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C
TS :maximum windup pain rating - first windup pain rating (0-100). Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to left forearm. In order to assess temporal summation, three sequences of 10 heat pulses each (with stimulus temperatures of 46 degrees C, 48 degrees C, and 50 degrees C, in random order) were applied to left dorsal forearm. The thermode remains in fixed position during administration of 10 heat pulses that constitute a sequence. Within each sequence, successive thermal pulses at a given temperature are delivered for a duration of approximately 0.5 sec each, with a 2.5-sec inter-pulse interval. The rate of rise \& fall of the thermode temp. is set at the device max .of 10 degrees C / S. Subjects verbally rate the perceived intensity of each thermal pulse on a 0-100 rating scale \& may terminate the procedure at any time.100=max tolerable intensity
Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
时间窗: Mean of baseline, 6 week follow-up and 12 week follow-up
The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Pain was assessed on a scale of 0-100, with 0 being absolutely no pain and 100 being maximum pain.
次要结局
- Heat Pain Threshold(Mean of baseline, 6 week follow-up and 12 week follow-up)
- Heat Pain Tolerance (HPTOL)(Mean of baseline, 6 week follow-up and 12 week follow-up)
- Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary(Mean of baseline, 6 week follow-up and 12 week follow-up)
- Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale(Mean of baseline, 6 week follow-up and 12 week follow-up)
- Pressure Pain Threshold(Mean of baseline, 6 week follow-up and 12 week follow-up)
- Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale(Mean of baseline, 6 week follow-up and 12 week follow-up)
- Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary(Mean of baseline, 6 week follow-up and 12 week follow-up)