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New treatment option for Knee Osteoarthritis
Official title Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06580561
What this study is testing
- What it's testing
- This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain. The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Self-reported physician diagnosis of knee osteoarthritis
- Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
- Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
- If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no...
- Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener
You likely can't join if
- Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis)
- Active malignancy
- Neurological conditions (e.g., movement disorders)
- Any medical condition which would make graded increase of physical activity unsuitable (determined by a positive answer to the question: "Has a...
- Unable to understand English sufficiently to take part in the intervention.
- Unable to provide electronic informed consent.
See the full eligibility criteria
- Self-reported physician diagnosis of knee osteoarthritis
- Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
- Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
- If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no other changes to medications for pain or sleep during the active study...
- Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener
- Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis)
- Active malignancy
- Neurological conditions (e.g., movement disorders)
- Any medical condition which would make graded increase of physical activity unsuitable (determined by a positive answer to the question: "Has a doctor or healthcare professional advised you to avoid physical activity...
- Unable to understand English sufficiently to take part in the intervention.
- Unable to provide electronic informed consent.
- Evidence of significant cognitive impairment (i.e., ≥2 errors on a 6-item cognitive screener).
- Presence of severe psychiatric disorder.
- Currently participating in an treatment trial or a pain or sleep management program or having done so in the past six months.
- Visual or hearing impairment that would prevent use of the intervention.
- Serious physical health concerns necessitating surgery or with a prognosis \<6 months
- Irregular sleep-wake schedule, e.g., shift work.
- Self-report of diagnosis of a specific sleep disorder other than insomnia that is not currently adequately treated, e.g., sleep apnea or narcolepsy.
- Currently meeting or exceeding physical activity guidance from the U.S. Department of Health and Human Services (noted in protocol)
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.