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Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis of the Knee; Insomnia; Knee Pain

Intervention: Cognitive Behavioral Therapy for Insomnia (Behavioral)

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Kathi L. Heffner, PhD, Principal Investigator, Affiliation: University of Rochester
Wilfred Pigeon, PhD, Principal Investigator, Affiliation: University of Rochester

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.

Clinical Details

Official title: Slow Wave Sleep and Inflammatory Processes in Pain

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome:

Change from baseline in minutes of time in slow wave sleep

Change from baseline in relative power of delta EEG activity to index slow wave sleep activity

Change from baseline in nociception flexion reflex threshold

Change from baseline in electrocutaneous pain threshold

Change from baseline in inflammatory cytokine responses to pain

Change from baseline in Western Ontario and McMaster University OA Index

Change from baseline in Knee Pain Scale score

Eligibility

Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: February 2013
Last updated: April 2, 2015

Page last updated: August 23, 2015

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