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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Knee Pain; Osteoarthritis of the Knee
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Insomnia treatment; Cognitive Behavioral Therapy for Insomnia	Behavioral: Cognitive Behavioral Therapy for Insomnia; 6-week behavioral treatment for insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in minutes of time in slow wave sleep	baseline and 10 weeks
Change from baseline in relative power of delta EEG activity to index slow wave sleep activity	baseline and 10 weeks
Change from baseline in nociception flexion reflex threshold	baseline and 10 weeks
Change from baseline in electrocutaneous pain threshold	baseline and 10 weeks
Change from baseline in inflammatory cytokine responses to pain	baseline and 10 weeks
Change from baseline in Western Ontario and McMaster University OA Index	baseline and 10 weeks
Change from baseline in Knee Pain Scale score	baseline and 10 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Wilfred Pigeon, PhD, University of Rochester; Principal Investigator: Kathi L. Heffner, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 7, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimate): September 12, 2012

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 28, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Inflammation; Osteoarthritis; Chronic pain; Insomnia; Inflammatory cytokines; Cognitive Behavioral Therapy for Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: RSRB00044088; R21AG041942-01A1 (U.S. NIH Grant/Contract)