N/A
Completed N=30
Insomnia and Osteoarthritis Study
Source: ClinicalTrials.gov NCT00374556 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Wake After Sleep Onset (WASO) — 117.33; 88.0; 81.00; 65.56 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wake After Sleep Onset (WASO) |
117.33; 88.0; 81.00; 65.56; 61.94; 58.57 | — |
| PRIMARY Time in Bed |
464.00; 608.00; 506.00; 577.77; 523.33; 592.85 | — |
| PRIMARY Sleep Latency (SL) |
58.33; 47.50; 45.00; 33.33; 31.38; 41.42 | — |
| PRIMARY Number of Awakenings |
3.53; 3.70; 3.06; 3.11; 2.38; 3.42 | — |
| PRIMARY Total Sleep Time (TST) |
255.66; 370.50; 339.33; 454.44; 409.44; 437.14 | — |
| PRIMARY Sleep Efficiency (SE) |
55.54; 62.44; 66.31; 77.48; 80.07; 75.06 | — |
| PRIMARY Sleep Quality (SQ) |
44.40; 37.90; 52.46; 55.33; 59.16; 55.71 | — |
| PRIMARY WASO as Assessed by Actigraphy |
64.70; 59.43; 56.30; 56.06; 59.70; 65.29 | — |
| PRIMARY TST as Assessed by Actigraphy |
340.07; 367.95; 337.93; 405.88; 336.84; 394.77 | — |
| PRIMARY Sleep Efficiency as Assessed by Actigraphy |
73.32; 76.83; 74.77; 79.94; 73.95; 75.16 | — |
| PRIMARY Sleep Latency as Assessed by Actigraphy |
46.25; 26.79; 39.31; 24.87; 24.71; 38.89 | — |
| PRIMARY Insomnia Severity Index (ISI) Mean Total Scores |
15.64; 16.64; 12.57; 10.71; 10.25; 13 | — |
| PRIMARY Diffuse Noxious Inhibitory Control (DNIC) Index Scores |
1.23; 1.19; 1.26; 1.23; 1.16; 1.14 | — |
| PRIMARY Temporal Summation (TS) |
9.20; 7.80; 6.41; 6.50; 5.22; 3.33 | — |
| PRIMARY Mean Level of Pain Experienced Throughout the Day |
48.79; 52.40; 42.21; 44.43; 38.12; 42.88 | — |
| PRIMARY Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale |
21.62; 24.88; 19.18; 24.41; 14.85; 19.89 | — |
| SECONDARY Heat Pain Threshold |
43.38; 42.77; 43.41; 42.19; 43.31; 42.49 | — |
| SECONDARY Heat Pain Tolerance (HPTOL) |
47.65; 46.56; 47.54; 46.87; 47.92; 46.67 | — |
| SECONDARY Pressure Pain Threshold |
300.91; 267.93; 322.24; 287.29; 381.92; 309.15 | — |
| SECONDARY Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale |
64.32; 74.69; 62.26; 79.71; 56.13; 70.44 | — |
| SECONDARY Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary |
57.61; 52.73; 60.60; 49.44; 65.00; 49.40 | — |
| SECONDARY Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary |
50.40; 45.78; 51.68; 45.86; 50.71; 47.04 | — |
| SECONDARY Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale |
10.17; 12.86; 7.55; 12.17; 6.86; 11.32 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT00374556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.