Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
This study has been completed.
Sponsor:
University of Rochester
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kathi Heffner, University of Rochester
ClinicalTrials.gov Identifier:
NCT01683799
First received: September 7, 2012
Last updated: September 28, 2016
Last verified: September 2016
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Purpose
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 | Intervention |
|---|---|
|
Osteoarthritis of the Knee Insomnia Knee Pain |
Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Slow Wave Sleep and Inflammatory Processes in Pain |
Resource links provided by NLM:
Further study details as provided by University of Rochester:
Primary Outcome Measures:
- Change from baseline in minutes of time in slow wave sleep [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
- Change from baseline in relative power of delta EEG activity to index slow wave sleep activity [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
- Change from baseline in nociception flexion reflex threshold [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
- Change from baseline in electrocutaneous pain threshold [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
- Change from baseline in inflammatory cytokine responses to pain [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Western Ontario and McMaster University OA Index [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Knee Pain Scale score [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | February 2013 |
| Study Completion Date: | August 2016 |
| Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Insomnia treatment
Cognitive Behavioral Therapy for Insomnia
|
Behavioral: Cognitive Behavioral Therapy for Insomnia
6-week behavioral treatment for insomnia
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683799
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683799
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
| 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 |
| Study First Received: | September 7, 2012 |
| Last Updated: | September 28, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 30, 2016