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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 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. The trial reports 1 study location across 1 state.
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.
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, categorized as NA. 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 33 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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