Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

University of Rochester

Status

Completed

Conditions

Osteoarthritis of the Knee

Insomnia

Knee Pain

Treatments

Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01683799

RSRB00044088

R21AG041942-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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