Slow Wave Sleep and Inflammatory Processes in Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis of the Knee
- Sponsor
- University of Rochester
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change from baseline in nociception flexion reflex threshold
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Kathi Heffner
Associate Professor of Psychiatry
University of Rochester
Eligibility 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
Outcomes
Primary Outcomes
Change from baseline in nociception flexion reflex threshold
Time Frame: baseline and 10 weeks
Change from baseline in electrocutaneous pain threshold
Time Frame: baseline and 10 weeks
Change from baseline in minutes of time in slow wave sleep
Time Frame: baseline and 10 weeks
Change from baseline in relative power of delta EEG activity to index slow wave sleep activity
Time Frame: baseline and 10 weeks
Change from baseline in inflammatory cytokine responses to pain
Time Frame: baseline and 10 weeks
Change from baseline in Western Ontario and McMaster University OA Index
Time Frame: baseline and 10 weeks
Change from baseline in Knee Pain Scale score
Time Frame: baseline and 10 weeks