Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

This study is ongoing, but not recruiting participants.
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kathi Heffner, University of Rochester Identifier:
First received: September 7, 2012
Last updated: September 18, 2015
Last verified: September 2015

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 Intervention
Osteoarthritis of the Knee
Knee Pain
Behavioral: Cognitive Behavioral Therapy for Insomnia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Slow Wave Sleep and Inflammatory Processes in Pain

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Change from baseline in minutes of time in slow wave sleep [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in relative power of delta EEG activity to index slow wave sleep activity [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in nociception flexion reflex threshold [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in electrocutaneous pain threshold [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in inflammatory cytokine responses to pain [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Western Ontario and McMaster University OA Index [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Knee Pain Scale score [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insomnia treatment
Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia
6-week behavioral treatment for insomnia
No Intervention: Control


Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01683799

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)
Principal Investigator: Kathi L. Heffner, PhD University of Rochester
Principal Investigator: Wilfred Pigeon, PhD University of Rochester
  More Information

No publications provided

Responsible Party: Kathi Heffner, Associate Professor of Psychiatry, University of Rochester Identifier: NCT01683799     History of Changes
Other Study ID Numbers: RSRB00044088, R21AG041942-01A1
Study First Received: September 7, 2012
Last Updated: September 18, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Chronic pain
Cognitive Behavioral Therapy for Insomnia
Inflammatory cytokines

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on October 06, 2015