Clinical trial NCT01683799: Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
Official title: Slow Wave Sleep and Inflammatory Processes in Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Insomnia
Knee Pain
Keywords: Osteoarthritis
Insomnia
Chronic pain
Cognitive Behavioral Therapy for Insomnia
Inflammation
Inflammatory cytokines
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-09-12
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change from baseline in minutes of time in slow wave sleep
timeFrame: baseline and 10 weeks
measure: Change from baseline in relative power of delta EEG activity to index slow wave sleep activity
timeFrame: baseline and 10 weeks
measure: Change from baseline in nociception flexion reflex threshold
timeFrame: baseline and 10 weeks
measure: Change from baseline in electrocutaneous pain threshold
timeFrame: baseline and 10 weeks
measure: Change from baseline in inflammatory cytokine responses to pain
timeFrame: baseline and 10 weeks
measure: Change from baseline in Western Ontario and McMaster University OA Index
timeFrame: baseline and 10 weeks
measure: Change from baseline in Knee Pain Scale score
timeFrame: baseline and 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Kathi L. Heffner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Wilfred Pigeon, PhD
role: PRINCIPAL_INVESTIGATOR
References: