Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

NCT ID: NCT01683799

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-08-31

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.

Conditions

Osteoarthritis of the Knee; Insomnia; Knee Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Insomnia treatment

Cognitive Behavioral Therapy for Insomnia

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

6-week behavioral treatment for insomnia

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy for Insomnia

6-week behavioral treatment for insomnia

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kathi Heffner

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathi L. Heffner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Wilfred Pigeon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

R21AG041942-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RSRB00044088

Identifier Type: -

Identifier Source: org_study_id