Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2014 by University of Rochester

Sponsor:

Collaborator:

National Institute on Aging (NIA)

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

History of Changes

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:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

National Institute on Aging (NIA)

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 Arthritis	Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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