NCT06580561 Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
| NCT ID | NCT06580561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2028-02-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2024-11-04 with a primary completion date of 2028-02-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 period. * Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener Exclusion Criteria: * 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 for any reason?"). * 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 interventional 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)
Contact & Investigator
Daniel Whibley, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06580561 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06580561 currently recruiting?
Yes, NCT06580561 is actively recruiting participants. Contact the research team at trederj@med.umich.edu for enrollment information.
Where is the NCT06580561 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06580561 clinical trial?
NCT06580561 is sponsored by University of Michigan. The principal investigator is Daniel Whibley, PhD at University of Michigan. The trial plans to enroll 288 participants.