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NCT07532070 · ClinicalTrials.gov registry record · NA
Comparative Effectiveness OF Exercise, Cognitive Behavioural Therapy, AND Their Combination FOR People With Chronic Musculoskeletal Pain AND Poor Sleep: Sleepfit Trial
A NA study, sponsored by University of Sydney.
- Recruiting
- Registry status
- NA
- Development phase
- 384
- Enrollment target
NCT07532070: Recruiting NA study, sponsored by University of Sydney.
NCT07532070 is a NA study that is actively recruiting participants, run by University of Sydney. The registered enrollment target is 384 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07532070, a NA study, is actively recruiting participants, sponsored by University of Sydney.
- RECRUITING
- Registry status
- NA
- Development phase
- 384 participants
- Enrollment target
Study Summary
This study aims to find out which lifestyle approach works best for people with chronic musculoskeletal pain (such as low back pain or hip/knee osteoarthritis) who also have poor sleep. Participants will be randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. Each program includes up to 10 online sessions with a physiotherapist and guidance on managing pain, sleep, and physical activity. We will measure changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples. The goal is to improve understanding of non-medication treatments for pain and sleep problems.
Primary Outcome
Average pain severity at the designated study site will be measured using a 0-10 Numerical Rating Scale, with higher scores indicating greater pain. Assessments will be conducted at baseline and at 2, 6, and 12 months. Primary intervention efficacy will be evaluated by between-group differences in change in average NRS pain from baseline to 6 months.
Interventions
- BEHAVIORAL CBT-I
- BEHAVIORAL Aerobic physical activity
- BEHAVIORAL Combined aerobic physical activity and CBT-I
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2026-04 |
| Est. Completion | 2029-04 |
| Phase | NA |
What NCT07532070 shows while recruiting
NCT07532070 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which CBT-I is the first listed.
NCT07532070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07532070 about?
NCT07532070 is a clinical study titled "Comparative Effectiveness OF Exercise, Cognitive Behavioural Therapy, AND Their Combination FOR People With Chronic Musculoskeletal Pain AND Poor Sleep: Sleepfit Trial". This study aims to find out which lifestyle approach works best for people with chronic musculoskeletal pain (such as low back pain or hip/knee osteoarthritis) who also have poor sleep. Participants will be randomly assigned to one of three 12-month home-based programs: exercise, cognitive behaviora...
What is the current status of trial NCT07532070?
This trial is currently recruiting. It is a NA study. The enrollment target is 384 participants. The study started on 2026-04. Estimated completion is 2029-04.
What interventions are being tested in trial NCT07532070?
The interventions under investigation include: CBT-I (BEHAVIORAL), Aerobic physical activity (BEHAVIORAL), Combined aerobic physical activity and CBT-I (BEHAVIORAL).
Who is sponsoring clinical trial NCT07532070?
This trial is sponsored by University of Sydney, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07532070's enrollment target sits among peer trials
384 271st of 2000 higher than 1,728 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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