Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
CompletedNot applicableNCT01683799
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Slow Wave Sleep and Inflammatory Processes in Pain
- Conditions
- Osteoarthritis of the Knee
- Insomnia
- Knee Pain
- Interventions
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- Sponsor
- University of Rochester
- Collaborators
- National Institute on Aging (NIA)
- Start date
- 2013-02
- Primary completion
- 2015-07
- Sex
- All
- Age range
- from 50 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01683799