Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
This study is not yet open for participant recruitment.
Verified September 2012 by University of Rochester
Sponsor:
University of Rochester
Collaborator:
Information provided by (Responsible Party):
Kathi Heffner, University of Rochester
ClinicalTrials.gov Identifier:
NCT01683799
First received: September 7, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
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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-related Pain Insomnia |
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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | September 2014 (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 |
| 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, antipsychotics, mood stabilizers, sedative-hypnotics, opiate analgesics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683799
Contacts
| Contact: Kathi L. Heffner, PhD | 585-273-4786 | kathi_heffner@urmc.rochester.edu |
Locations
| United States, New York | |
| University of Rochester Medical Center | Not yet recruiting |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: Kathi L. Heffner, PhD | |
| Principal Investigator: Wilfred Pigeon, PhD | |
| Sub-Investigator: Michael Maloney, MD | |
| Sub-Investigator: Christopher R. France, PhD | |
Sponsors and Collaborators
University of Rochester
Investigators
| Principal Investigator: | Kathi L. Heffner, PhD | University of Rochester |
| Principal Investigator: | Wilfred Pigeon, PhD | University of Rochester |
More Information
No publications provided
| Responsible Party: | Kathi Heffner, Asst Professor, 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 7, 2012 |
| 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 Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013