| Study summary: |
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Sleep disturbance and pain are two of the most common and disabling symptoms of OA. Sleep disturbances have been shown to worsen clinical pain by impairing some of the body's central pain processing mechanisms. Sufficient research is lacking, however, on what treatments may be effective for sleep disturbance in people with OA or whether normalization of sleep patterns in people with OA will reduce their pain. This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA.
Participants in Phase 1 of this study will be separated into the following four groups: people with OA and insomnia; people with OA, but without insomnia; people without OA, but with insomnia; and people without OA or insomnia. All participants will attend three study visits. During Visit 1, participants will complete questionnaires and an interview and will provide a urine sample and a set of recent x-rays. A diary, which will be used to record activity levels for 2 weeks, will also be given to all participants. At Visit 2, participants will undergo pain testing and complete an in-home sleep study. Participants who have knee pain will also be examined by a rheumatologist.
Participants in Phase 1 who have both knee OA and insomnia will be asked to continue into Phase 2, which will last 8 months. These participants will be randomly assigned to receive two different forms of behavioral treatment, cognitive behavior therapy (CBT) or a behavioral desensitization treatment.
Participants assigned to both treatments will meet with a psychologist once a week for 8 weeks. Participants will learn new sleeping habits and mental exercises designed to reduce arousal and alertness while trying to sleep. All participants will attend four assessment visits over the course of Phase 2.
The first visit will occur at Week 4 and will include completing questionnaires and undergoing pain testing. The second visit will occur at Week 8 and will include the same questionnaires, further pain testing, and an in-home sleep study. Two weeks before assessment Visit 3, participants will receive a diary in the mail, which they will use to keep track of their pain, sleep, medications, and symptoms until Visit 3. Assessment Visit 3 will take place at Month 5 and will include the same procedures followed during Visit 2. Participants will complete a second diary 2 weeks before Visit 4. At Visit 4, which will occur at Month 8, the same procedures completed at Visits 2 and 3 will be repeated. |
| Qualified participants must: |
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• Be 50 years of age or older
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Good sleeper or poor sleeper
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Have pain/osteoarthritis in the knee |
| Participants will receive: |
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Participants will be paid a total of $110.00 if they fully complete all study visits. If they leave the study early for any reasons, partial payment will be provided as follows: $30.00 for completing Visit 1 procedures, $20.00 for completing Visit 2 pain testing procedures, $25.00 for completing Visit 2 sleep study procedures, and $35.00 after they return study equipment at the conclusion of participation in the study. Additionally, if they complete the first two visits of the study, they will be eligible to receive a referral payment of $25 for every person that the participant refers who in turn completes the first two visits of the study. Participants can recruit up to 5 people. Payment will be provided after they have completed or discontinued participation.
Participants eligible for our insomnia treatment program will receive up to $205.00 for their participation. |