Sleep in Osteoarthritis Project

Completed · Not applicable

Conditions studied: Sleep Initiation and Maintenance Disorders, Osteoarthritis

In brief

Osteoarthritis (OA) is one of the most common diseases and one of the leading causes of disability in the world. People with OA frequently experience sleep disturbances, primarily due to pain. Although insomnia is a known consequence of OA, recent studies have shown that it may also worsen clinical pain by interfering with the body's responses to painful stimuli. This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA. The study will test whether improvement in clinical pain are mediated by changes in certain types of pain processing.

Key facts

Study ID

NCT00592449

Run by

Johns Hopkins University

People needed

209

Starts

2008-04-01

Expected to finish

2014-01-01

Last updated by the study team

2019-05-23

Who can join

Age: 35 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For all participants:
• Age ≥ 50 ; or 35 ≥ if KOA/Insomnia group
• For participants with knee OA:
• Meets American College of Rheumatology (ACR) criteria for knee OA
• Shows radiographic evidence of Kellgren-Lawrence Grade OA greater than or equal to 1
• Experiences knee pain more than 5 days per week for more than 6 months
• Reports at least typical arthritic pain (a score of at least 2 out of 10, with 0 being no pain and 10 being the most extreme pain imaginable)
• Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen must be on a stable dose for at least 1 month prior to study entry
• Not scheduled for arthroplasty or surgery during projected period of study participation
• For participants with insomnia:
• A sleep maintenance insomnia profile is evident both at study entry (based on retrospective reports) and as an average profile from 2 weeks of sleep diaries
• Meets diagnostic criteria for insomnia due to knee OA only or for primary insomnia
• Reports total sleep time less than 6.5 hours
• Middle insomnia symptom frequency of more than 3 nights per week for more than 1 month
• For participants without insomnia:
• Meets research diagnostic criteria for normal sleepers
• Insomnia Severity Index of less than 10
• Epworth Sleepiness score of less than 10
• Pittsburgh Sleep Quality Index score of less than 5
• Wake After Sleep Onset Time is under 30 minutes
• Sleep efficiency percentage is greater than 85%
• Total sleep time is greater than 6.5 hours
• For participants without knee OA and without insomnia:
• Free from any acute pain or injury
• No recent history of chronic pain within 3 years prior to study entry (pain severity report greater than 2 out of 10 more than 2 days per week for 6 months)

You may not qualify if…

• Sleep disorders other than insomnia (e.g., obstructive sleep apnea, periodic limb movement disorder, etc.)
• Apnea/Hypopnea Index (AHI) of greater than 15
• Significant rheumatologic or painful disorders other than knee OA (including fibromyalgia, rheumatoid arthritis, neuralgia, etc.)
• Any major medical diseases known to impact sleep or cause pain (including chronic obstructive pulmonary disease, diabetes, congestive heart failure, seizure disorder, Raynaud's phenomenon, etc.)
• Dementia or cognitive impairment, defined as Mini Mental State Exam score of less than 24
• Current or recent history of major psychiatric disorders (within 3 months prior to study entry)
• History of schizophrenia or bipolar I disorder
• Center for Epidemiologic Studies of Depression Scale (CES-D) greater than or equal to 27 or suicidal ideation
• Current or history of substance abuse (within 6 months prior to study entry)
• Use of antidepressants, antipsychotics, or mood stabilizers more than 3 days per week in the past 2 months- Note: only applies to groups other than KOA/Insomnia
• Use of narcotics (opioids), myorelaxants, sedatives, or anticonvulsants more than 3 days per week within 1 month prior to study entry
• Unwilling or unable to discontinue all use of certain medications by 1 week prior to study entry
• Refuses to contact physician to obtain relevant medical record information
• Pregnancy or plans to become pregnant within 6 months
• Positive toxicology test (benzodiazepines and receptor agonists, barbiturates, opioids, tetrahydrocannabinol, alcohol, and stimulants)

Where it is running

• Johns Hopkins Bayview Medical Center 5510 Nathan Shock Dr, Ste 100 — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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