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Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01683799
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kathi Heffner, University of Rochester

September 7, 2012
September 12, 2012
September 30, 2016
February 2013
July 2015   (Final data collection date for primary outcome measure)
  • Change from baseline in minutes of time in slow wave sleep [ Time Frame: baseline and 10 weeks ]
  • Change from baseline in relative power of delta EEG activity to index slow wave sleep activity [ Time Frame: baseline and 10 weeks ]
  • Change from baseline in nociception flexion reflex threshold [ Time Frame: baseline and 10 weeks ]
  • Change from baseline in electrocutaneous pain threshold [ Time Frame: baseline and 10 weeks ]
  • Change from baseline in inflammatory cytokine responses to pain [ Time Frame: baseline and 10 weeks ]
  • Change from baseline in Western Ontario and McMaster University OA Index [ Time Frame: baseline and 10 weeks ]
  • Change from baseline in Knee Pain Scale score [ Time Frame: baseline and 10 weeks ]
Same as current
Complete list of historical versions of study NCT01683799 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
Slow Wave Sleep and Inflammatory Processes in Pain
The purpose if the study is to determine whether improving sleep, especially slow wave or "deep" sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity and inflammatory responses to pain, and improves OA-related pain.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
  • Osteoarthritis of the Knee
  • Insomnia
  • Knee Pain
Behavioral: Cognitive Behavioral Therapy for Insomnia
6-week behavioral treatment for insomnia
  • Experimental: Insomnia treatment
    Cognitive Behavioral Therapy for Insomnia
    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
50
August 2016
July 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 50-75 years of age (for women, post-menopausal)
  • Kellgren-Lawrence grade II radiographic evidence of OA affecting one or both knees
  • knee pain on most days for ≥ 6 months
  • self-reported disability due to knee pain for ≥ 2 of the following: walking, kneeling, ascending or descending stairs, or performing daily activities
  • willing and able to avoid all prescription and non-prescription, non-opiate pain medication for 48 hours prior to testing and all narcotic pain medication for 2 weeks prior to testing
  • meets research diagnostic criteria for sleep maintenance insomnia

Exclusion Criteria:

  • health conditions with immunological components or undergoing or taking immunosuppressive therapies
  • conditions contraindicated for or potentially limiting ability to conduct NFR and/or cold pressor test (e.g. Raynaud's syndrome; seizures; prior MI; respiratory conditions; leg/hip nerve damage; BMI ≥ 32)
  • sleep disorders other than insomnia
  • dementia or cognitive impairment
  • history of schizophrenia or bipolar I disorder; current or recent history (within 3 months) of major psychiatric disorders
  • current depressive symptomatology or current suicidality
  • active substance dependence
  • untreated hypertension
  • use of antidepressants (stable use for 3 months okay), antipsychotics, mood stabilizers, sedative-hypnotics, opiate analgesics
Sexes Eligible for Study: All
50 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01683799
RSRB00044088
R21AG041942-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Kathi Heffner, University of Rochester
University of Rochester
National Institute on Aging (NIA)
Principal Investigator: Kathi L. Heffner, PhD University of Rochester
Principal Investigator: Wilfred Pigeon, PhD University of Rochester
University of Rochester
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP