OsteoarthritisNCT00374556
Insomnia and Osteoarthritis Study
A study testing Eszopiclone in people with Osteoarthritis and Insomnia, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Osteoarthritis, Insomnia
- What is being tested?
- Eszopiclone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.
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.
- Conditions
- Osteoarthritis, Insomnia
- Being tested
- Placebo, Eszopiclone
- Keywords
- eszopiclone, insomnia
- Medical subject headings
- Osteoarthritis, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
3mg placebo capsule, once daily at bedtime
EszopicloneDrug
3mg capsule, once daily at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone | Experimental | Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks Receives: Drug: Eszopiclone |
| Placebo | Placebo comparator | 3mg placebo capsule, once daily at bedtime for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake After Sleep Onset (WASO)
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
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Time in Bed
Total time in bed, in minutes
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Sleep Latency (SL)
Sleep Latency: time taken to fall asleep, in minutes (as recorded in daily sleep diary)
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Number of Awakenings
As recorded in daily sleep diary
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Total Sleep Time (TST)
minutes spent asleep as recorded in daily sleep diary
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Sleep Efficiency (SE)
[(TST/ TIB)X 100], (%) as recorded in daily sleep diary
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Sleep Quality (SQ)
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)
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
WASO as Assessed by Actigraphy
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.
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
TST as Assessed by Actigraphy
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
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Sleep Efficiency as Assessed by Actigraphy
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%.
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Sleep Latency as Assessed by Actigraphy
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).
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Insomnia Severity Index (ISI) Mean Total Scores
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
Measured: Mean of baseline, 6 week follow-up, and 12 week follow-up
Diffuse Noxious Inhibitory Control (DNIC) Index Scores
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.
Measured: Mean of baseline, 6 week follow-up and 12 week follow-up
Temporal Summation (TS)
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
Measured: Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C
Mean Level of Pain Experienced Throughout the Day
Assessed using a Daily Pain Diary with a scale 0-100, 0 being no pain, 100 being the most severe/intense
Measured: Mean of baseline, 6 week follow-up and 12 week follow-up
Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
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.
Measured: Mean of baseline, 6 week follow-up and 12 week follow-up
Secondary outcomes (7)
Heat Pain Threshold
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 the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitizationHPTh was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of heat pain threshold were conducted. Averages of both trials are presented from respective time point below. Subjects push a button when the stimulus "first feels painful" The temperature (degrees Celsius) at the time button is pushed is automatically recorded.
Measured: Mean of baseline, 6 week follow-up and 12 week follow-up
Heat Pain Tolerance (HPTOL)
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 the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitization. HPTOL was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of HPTOL were conducted. An average of both trials at each respective time point is presented below. Subjects push a button when the stimulus "becomes intolerable." The temperature (degrees Celsius) at the time button is pushed to terminate the stimulation is automatically recorded.
Measured: Mean of baseline, 6 week follow-up and 12 week follow-up
Pressure Pain Threshold
A Somedic algometer was used to assess pressure pain threshold (PPTh) similar to previous studies. The algometer's 1cm2 rubber probe was placed over the muscle belly, with the pressure increased steadily at a constant rate (30kPA/Sec), until the subject indicated that s/he "first felt pain." PPTh was assessed 2 times each, bilaterally, at (in a randomized order) the masseter muscle trapezius muscle, and at the proximal third of the brachioradialis muscle (forearm). The scores from each location were averaged for each participant at that respective time point. The same site was never stimulated consecutively. At least 90 s were maintained between successive stimuli
Measured: 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
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. Disability was assessed on a VAS of 0-100, with 0 being absolutely no disability and 100 being maximum disability.
Measured: 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
The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Physical Component Summary was used here as a global index of physical health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.
Measured: 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
The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Mental Component Summary was used here as a global index of mental health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.
Measured: 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
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. Joint Stiffness was assessed on a VAS scale of 0-20, with 0 being no joint stiffness, and 20 being maximum stiffness.
Measured: Mean of baseline, 6 week follow-up and 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael T. Smith, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374556
- Sponsor's protocol ID
- NA_00001703
- Status last verified
- Mar 2019
- First submitted
- 8 Sep 2006
- Last updated
- 14 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.
- ClinicalTrials.gov ID
- NCT00374556
- Acronym / sponsor ID
- NA_00001703
- Conditions
- Osteoarthritis, Insomnia
- Keywords
- eszopiclone, insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Posted 9 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eszopiclone | Experimental | Drug: EszopicloneEszopiclone 3mg capsules, once daily at bedtime for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo3mg placebo capsule, once daily at bedtime for 12 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo3mg placebo capsule, once daily at bedtime | Drug | Placebo |
| Eszopiclone3mg capsule, once daily at bedtime | Drug | Eszopiclone |
Primary outcome
Wake After Sleep Onset (WASO)
Time frame: 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
Time in Bed
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Total time in bed, in minutes
Sleep Latency (SL)
Time frame: 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
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
As recorded in daily sleep diary
Total Sleep Time (TST)
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
minutes spent asleep as recorded in daily sleep diary
Sleep Efficiency (SE)
Time frame: 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)
Time frame: 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
Time frame: 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.
TST as Assessed by Actigraphy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Mean Level of Pain Experienced Throughout the Day
Time frame: 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
Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
Time frame: 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.
7 secondary outcomes
Heat Pain Threshold
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Heat Pain Tolerance (HPTOL)
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Pressure Pain Threshold
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael T. Smith, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eszopiclone in people with Osteoarthritis and Insomnia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake After Sleep Onset (WASO) (time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019; AzTrials last refreshed its copy on 31 Oct 2026.