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Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Insomnia Knee Pain Behavioral: Cognitive Behavioral Therapy for Insomnia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Slow Wave Sleep and Inflammatory Processes in Pain
Study Start Date : February 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Insomnia treatment
Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia
6-week behavioral treatment for insomnia

No Intervention: Control

Primary Outcome Measures :
  1. Change from baseline in minutes of time in slow wave sleep [ Time Frame: baseline and 10 weeks ]
  2. Change from baseline in relative power of delta EEG activity to index slow wave sleep activity [ Time Frame: baseline and 10 weeks ]
  3. Change from baseline in nociception flexion reflex threshold [ Time Frame: baseline and 10 weeks ]
  4. Change from baseline in electrocutaneous pain threshold [ Time Frame: baseline and 10 weeks ]
  5. Change from baseline in inflammatory cytokine responses to pain [ Time Frame: baseline and 10 weeks ]
  6. Change from baseline in Western Ontario and McMaster University OA Index [ Time Frame: baseline and 10 weeks ]
  7. Change from baseline in Knee Pain Scale score [ Time Frame: baseline and 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01683799

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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute on Aging (NIA)
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Principal Investigator: Kathi L. Heffner, PhD University of Rochester
Principal Investigator: Wilfred Pigeon, PhD University of Rochester
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Responsible Party: Kathi Heffner, Associate Professor of Psychiatry, University of Rochester Identifier: NCT01683799    
Other Study ID Numbers: RSRB00044088
R21AG041942-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Keywords provided by Kathi Heffner, University of Rochester:
Chronic pain
Cognitive Behavioral Therapy for Insomnia
Inflammatory cytokines
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Sleep Initiation and Maintenance Disorders
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders