Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT01683799

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee Insomnia Knee Pain	Behavioral: Cognitive Behavioral Therapy for Insomnia	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Slow Wave Sleep and Inflammatory Processes in Pain

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insomnia treatment Cognitive Behavioral Therapy for Insomnia	Behavioral: Cognitive Behavioral Therapy for Insomnia 6-week behavioral treatment for insomnia
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Insomnia treatment

Cognitive Behavioral Therapy for Insomnia

Behavioral: Cognitive Behavioral Therapy for Insomnia

6-week behavioral treatment for insomnia

No Intervention: Control

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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