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Completed

NCT Number: NCT01683799

Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Chronic Pain Dyssomnias Inflammation Insomnia Joint Diseases Knee Pain Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

6-week behavioral treatment for insomnia

Primary outcomes

  1. Change from baseline in minutes of time in slow wave sleep

    Time frame: baseline and 10 weeks

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

    Time frame: baseline and 10 weeks

  3. Change from baseline in nociception flexion reflex threshold

    Time frame: baseline and 10 weeks

  4. Change from baseline in electrocutaneous pain threshold

    Time frame: baseline and 10 weeks

  5. Change from baseline in inflammatory cytokine responses to pain

    Time frame: baseline and 10 weeks

  6. Change from baseline in Western Ontario and McMaster University OA Index

    Time frame: baseline and 10 weeks

  7. Change from baseline in Knee Pain Scale score

    Time frame: baseline and 10 weeks

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Slow Wave Sleep and Inflammatory Processes in Pain

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Sep 12, 2012
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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