Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis of the Knee; Insomnia; Knee Pain
Intervention: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Rochester Official(s) and/or principal investigator(s): Kathi L. Heffner, PhD, Principal Investigator, Affiliation: University of Rochester Wilfred Pigeon, PhD, Principal Investigator, Affiliation: University of Rochester
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.
Clinical Details
Official title: Slow Wave Sleep and Inflammatory Processes in Pain
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Change from baseline in minutes of time in slow wave sleepChange from baseline in relative power of delta EEG activity to index slow wave sleep activity Change from baseline in nociception flexion reflex threshold Change from baseline in electrocutaneous pain threshold Change from baseline in inflammatory cytokine responses to pain Change from baseline in Western Ontario and McMaster University OA Index Change from baseline in Knee Pain Scale score
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
University of Rochester Medical Center, Rochester, New York 14642, United States
Additional Information
Starting date: February 2013
Last updated: April 2, 2015
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