Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
Completed · Not applicable
Conditions studied: Osteoarthritis of the Knee, Insomnia, Knee Pain
In brief
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.
Key facts
- Study ID
- NCT01683799
- Run by
- University of Rochester
- People needed
- 48
- Starts
- 2013-02-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2016-09-30
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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