Insomnia and Osteoarthritis Study

NCT00374556 | Completed Results

• 1 other identifier: NA_00001703
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis; Insomnia

Keywords

eszopiclone; insomnia

Outcome Measures

Primary Outcomes (16)

• 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

  Mean of baseline, 6 week follow-up, and 12 week follow-up

• Time in Bed

  Total time in bed, in minutes

  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)

  Mean of baseline, 6 week follow-up, and 12 week follow-up

• Number of Awakenings

  As recorded in daily sleep diary

  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

  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

  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)

  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.

  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

  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%.

  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).

  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

  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.

  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

  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

  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.

  Mean of baseline, 6 week follow-up and 12 week follow-up

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

Eszopiclone

EXPERIMENTAL

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Drug: Eszopiclone

Placebo

PLACEBO COMPARATOR

3mg placebo capsule, once daily at bedtime for 12 weeks

Drug: Placebo

Interventions

Placebo DRUG

3mg placebo capsule, once daily at bedtime

Placebo

Eszopiclone DRUG

3mg capsule, once daily at bedtime

Eszopiclone

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Michael Smith, PhD, Associate Professor of Psychiatry, Director of Behavioral Medicine
• Organization: Johns Hopkins University School of Medicine

msmith62@jhmi.edu

410-550-7000

Study Officials

• Michael T. Smith, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 14, 2019
• Results First Posted: November 9, 2017

Record last verified: 2019-03

Locations

US (1)