Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

Insomnia Clinical Trial

Official title:

Slow Wave Sleep and Inflammatory Processes in Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683799
• Other study ID #: RSRB00044088
• Secondary ID: R21AG041942-01A1
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: September 28, 2016
• Start date: February 2013
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Insomnia
• Knee Pain
• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
6-week behavioral treatment for insomnia

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in minutes of time in slow wave sleep		baseline and 10 weeks	No
Primary	Change from baseline in relative power of delta EEG activity to index slow wave sleep activity		baseline and 10 weeks	No
Primary	Change from baseline in nociception flexion reflex threshold		baseline and 10 weeks	No
Primary	Change from baseline in electrocutaneous pain threshold		baseline and 10 weeks	No
Primary	Change from baseline in inflammatory cytokine responses to pain		baseline and 10 weeks	No
Primary	Change from baseline in Western Ontario and McMaster University OA Index		baseline and 10 weeks	No
Primary	Change from baseline in Knee Pain Scale score		baseline and 10 weeks	No