Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Slow Wave Sleep and Inflammatory Processes in Pain

Conditions
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Insomnia, Osteoarthritis of the Knee, Knee Pain

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insomnia treatment<br>Cognitive Behavioral Therapy for Insomnia | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* 6-week behavioral treatment for insomnia<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Insomnia, Chronic pain, Cognitive Behavioral Therapy for Insomnia, Inflammation, Inflammatory cytokines