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Insomnia and Osteoarthritis Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374556
First Posted: September 11, 2006
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Osteoarthritis
Insomnia
Interventions: Drug: Placebo
Drug: Eszopiclone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
105 were assessed for eligibility. 75 were excluded based on not meeting inclusion criteria, 5 declined to participate, 1 was enrolled in another conflicting study. 30 were randomized to one of 2 arms.

Reporting Groups
  Description
Eszoplicone

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

Eszopiclone: 3mg capsule, once daily at bedtime

Placebo

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

Placebo: 3mg placebo capsule, once daily at bedtime


Participant Flow:   Overall Study
    Eszoplicone   Placebo
STARTED   14   16 
COMPLETED   13   15 
NOT COMPLETED   1   1 
Lost to Follow-up                1                0 
excluded at baseline due to medical cond                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics were only calculated for the 29 participants above.

Reporting Groups
  Description
Eszoplicone

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

Eszopiclone: 3mg capsule, once daily at bedtime

Placebo

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

Placebo: 3mg placebo capsule, once daily at bedtime

Total Total of all reporting groups

Baseline Measures
   Eszoplicone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   15   29 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.64  (5.18)   52.93  (6.64)   53.76  (5.94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  78.6%      8  53.3%      19  65.5% 
Male      3  21.4%      7  46.7%      10  34.5% 
Region of Enrollment 
[Units: Participants]
     
United States   14   15   29 
Kellgren Lawrence OA grade [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Right knee   2.08  (0.86)   1.53  (0.91)   1.79  (0.92) 
Left Knee   2.07  (1.07)   1.79  (1.05)   1.93  (1.05) 
[1] grade 0: no radiographic features of osteoarthritis (OA) are present grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
Kellgren Lawrence OA grade >=3 in either knee [1] 
[Units: Participants]
 6   4   10 
[1] grade 0: no radiographic features of OA are present grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.41  (5.21)   31.36  (6.53)   30.42  (5.91) 
Duration of OA 
[Units: Months]
Mean (Standard Deviation)
 87.7  (98.06)   108.5  (95.11)   95.6  (95.69) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Wake After Sleep Onset (WASO)   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

2.  Primary:   Time in Bed   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

3.  Primary:   Sleep Latency (SL)   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

4.  Primary:   Number of Awakenings   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

5.  Primary:   Total Sleep Time (TST)   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

6.  Primary:   Sleep Efficiency (SE)   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

7.  Primary:   Sleep Quality (SQ)   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

8.  Primary:   WASO as Assessed by Actigraphy   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

9.  Primary:   TST as Assessed by Actigraphy   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

10.  Primary:   Sleep Efficiency as Assessed by Actigraphy   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

11.  Primary:   Sleep Latency as Assessed by Actigraphy   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

12.  Primary:   Insomnia Severity Index (ISI) Mean Total Scores   [ Time Frame: Mean of baseline, 6 week follow-up, and 12 week follow-up ]

13.  Primary:   Diffuse Noxious Inhibitory Control (DNIC) Index Scores   [ Time Frame: Mean of baseline, 6 week follow-up and 12 week follow-up ]

14.  Primary:   Temporal Summation (TS)   [ Time Frame: Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C ]

15.  Primary:   Mean Level of Pain Experienced Throughout the Day   [ Time Frame: Mean of baseline, 6 week follow-up and 12 week follow-up ]

16.  Primary:   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 ]

17.  Secondary:   Heat Pain Threshold   [ Time Frame: Mean of baseline, 6 week follow-up and 12 week follow-up ]

18.  Secondary:   Heat Pain Tolerance (HPTOL)   [ Time Frame: Mean of baseline, 6 week follow-up and 12 week follow-up ]

19.  Secondary:   Pressure Pain Threshold   [ Time Frame: Mean of baseline, 6 week follow-up and 12 week follow-up ]

20.  Secondary:   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 ]

21.  Secondary:   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 ]

22.  Secondary:   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 ]

23.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Smith, PhD, Associate Professor of Psychiatry, Director of Behavioral Medicine
Organization: Johns Hopkins University School of Medicine
phone: 410-550-7000
e-mail: msmith62@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00374556     History of Changes
Other Study ID Numbers: NA_00001703
First Submitted: September 8, 2006
First Posted: September 11, 2006
Results First Submitted: August 25, 2017
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017