Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from baseline in minutes of time in slow wave sleep [ Time Frame: baseline and 10 weeks ]
2. Change from baseline in relative power of delta EEG activity to index slow wave sleep activity [ Time Frame: baseline and 10 weeks ]
3. Change from baseline in nociception flexion reflex threshold [ Time Frame: baseline and 10 weeks ]
4. Change from baseline in electrocutaneous pain threshold [ Time Frame: baseline and 10 weeks ]
5. Change from baseline in inflammatory cytokine responses to pain [ Time Frame: baseline and 10 weeks ]
6. Change from baseline in Western Ontario and McMaster University OA Index [ Time Frame: baseline and 10 weeks ]
7. Change from baseline in Knee Pain Scale score [ Time Frame: baseline and 10 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

National Institute on Aging (NIA)

Investigators

Principal Investigator:	Kathi L. Heffner, PhD	University of Rochester
Principal Investigator:	Wilfred Pigeon, PhD	University of Rochester

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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