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Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems
NCT06042686 · View on ClinicalTrials.gov ↗
Study Summary
Venous thromboembolism is prevalent, associated with a high degree of morbidity and mortality, and largely preventable. External mechanical compression is a standard of care for prevention, but compliance with traditional external mechanical compression devices is low due to patient reported issues with comfort, mobility, usability, noise, and sleep disturbances. The purpose of this study was to compare user-rated comfort, mobility, usability, noise, perceived sleep disturbance, and objective sleep disturbance for a novel external lower limb mechanical compression device as compared to a standard sequential compression device. Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall sequential compression device Express 9525 and the novel Recovery Force Movement and Compressions Device for 1 night each in their home while sleep was recorded with polysomnography. For each device, participants also completed questionnaires to assess usability, mobility, perceived noise disturbance, and perceived sleep disturbance.
Conditions Studied
Interventions
- DEVICE RF Health MAC Device
Study Locations (1)
Massachusetts
- University of Massachusetts Amherst — Amherst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2022-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06042686
The ClinicalTrials.gov registry entry for NCT06042686 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Amherst, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Deep Venous Thrombosis of Deep Femoral Vein appearing as the primary indexed condition, and to 1 intervention — of which RF Health MAC Device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06042686 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06042686 about?
NCT06042686 is a clinical study titled "Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems". Venous thromboembolism is prevalent, associated with a high degree of morbidity and mortality, and largely preventable. External mechanical compression is a standard of care for prevention, but compliance with traditional external mechanical compression devices is low due to patient reported issues ...
What is the current status of trial NCT06042686?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2021-12-01. Estimated completion is 2022-07-01.
What conditions does trial NCT06042686 study?
This clinical trial studies the following conditions: Deep Venous Thrombosis of Deep Femoral Vein. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06042686?
The interventions under investigation include: RF Health MAC Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06042686?
This trial is sponsored by University of Massachusetts, Amherst, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06042686 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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