Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

This study is currently recruiting participants.
Verified January 2014 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathi Heffner, University of Rochester
ClinicalTrials.gov Identifier:
NCT01683799
First received: September 7, 2012
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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
Insomnia
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: November 2014
Estimated Primary Completion Date: September 2014 (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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683799

Contacts
Contact: Kathi L. Heffner, PhD 585-273-4786 kathi_heffner@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Principal Investigator: Kathi L. Heffner, PhD         
Principal Investigator: Wilfred Pigeon, PhD         
Sub-Investigator: Michael Maloney, MD         
Sub-Investigator: Christopher R. France, PhD         
Sponsors and Collaborators
University of Rochester
Investigators
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, Asst Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01683799     History of Changes
Other Study ID Numbers: RSRB00044088, R21AG041942-01A1
Study First Received: September 7, 2012
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Sleep Initiation and Maintenance Disorders
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 20, 2014