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NCT06042686 · ClinicalTrials.gov registry record · NA
Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems
A NA study of Deep Venous Thrombosis of Deep Femoral Vein, sponsored by University of Massachusetts, Amherst.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06042686: Completed NA study of Deep Venous Thrombosis of Deep Femoral Vein, sponsored by University of Massachusetts, Amherst.
NCT06042686 is a NA study of Deep Venous Thrombosis of Deep Femoral Vein that has completed, run by University of Massachusetts, Amherst. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06042686, a NA study of Deep Venous Thrombosis of Deep Femoral Vein, has completed, sponsored by University of Massachusetts, Amherst.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Overall sleep will be measured using the Sleep Profiler. The Sleep Profiler is a battery powered portable device that provides a measure of the percentage of overall sleep vs wake in a given period of time.
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 |
What the finished NCT06042686 record still lists
NCT06042686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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.
NCT06042686 reports a single indexed study location in Massachusetts.
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.
What interventions are being tested in trial NCT06042686?
The interventions under investigation include: RF Health MAC Device (DEVICE).
Who is sponsoring clinical trial NCT06042686?
This trial is sponsored by University of Massachusetts, Amherst, which has 33 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06042686's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 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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