Back to results

Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

Primary Purpose

Osteoarthritis of the Knee, Insomnia, Knee Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy for Insomnia

About this trial

This is an interventional basic science trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Insomnia, Chronic pain, Cognitive Behavioral Therapy for Insomnia, Inflammation, Inflammatory cytokines

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Insomnia treatment

Control

Arm Description

Cognitive Behavioral Therapy for Insomnia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01683799

First Posted

September 7, 2012

Last Updated

September 28, 2016

Sponsor

University of Rochester

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT01683799

Brief Title

Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

Official Title

Slow Wave Sleep and Inflammatory Processes in Pain

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee, Insomnia, Knee Pain

Keywords

Osteoarthritis, Insomnia, Chronic pain, Cognitive Behavioral Therapy for Insomnia, Inflammation, Inflammatory cytokines

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insomnia treatment

Arm Type

Experimental

Arm Description

Cognitive Behavioral Therapy for Insomnia

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy for Insomnia

Intervention Description

6-week behavioral treatment for insomnia

Primary Outcome Measure Information:

Title

Change from baseline in minutes of time in slow wave sleep

Time Frame

baseline and 10 weeks

Title

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

Time Frame

baseline and 10 weeks

Title

Change from baseline in nociception flexion reflex threshold

Time Frame

baseline and 10 weeks

Title

Change from baseline in electrocutaneous pain threshold

Time Frame

baseline and 10 weeks

Title

Change from baseline in inflammatory cytokine responses to pain

Time Frame

baseline and 10 weeks

Title

Change from baseline in Western Ontario and McMaster University OA Index

Time Frame

baseline and 10 weeks

Title

Change from baseline in Knee Pain Scale score

Time Frame

baseline and 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathi L. Heffner, PhD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wilfred Pigeon, PhD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

We'll reach out to this number within 24 hrs