Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
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ClinicalTrials.gov Identifier: NCT01683799 |
Recruitment Status
:
Completed
First Posted
: September 12, 2012
Last Update Posted
: September 30, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis of the Knee Insomnia Knee Pain | Behavioral: Cognitive Behavioral Therapy for Insomnia | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | February 2013 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | August 2016 |

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 |
- 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 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 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 ]

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Ages Eligible for Study: | 50 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683799
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Kathi L. Heffner, PhD | University of Rochester | |
Principal Investigator: | Wilfred Pigeon, PhD | University of Rochester |
Responsible Party: | Kathi Heffner, Associate Professor of Psychiatry, University of Rochester |
ClinicalTrials.gov Identifier: | NCT01683799 History of Changes |
Other Study ID Numbers: |
RSRB00044088 R21AG041942-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | September 12, 2012 Key Record Dates |
Last Update Posted: | September 30, 2016 |
Last Verified: | September 2016 |
Keywords provided by Kathi Heffner, University of Rochester:
Osteoarthritis Insomnia Chronic pain |
Cognitive Behavioral Therapy for Insomnia Inflammation Inflammatory cytokines |
Additional relevant MeSH terms:
Osteoarthritis Sleep Initiation and Maintenance Disorders Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders |