Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems

Completed · Not applicable

Conditions studied: Deep Venous Thrombosis of Deep Femoral Vein

In brief

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.

Key facts

Study ID
NCT06042686
Run by
University of Massachusetts, Amherst
People needed
16
Starts
2021-12-01
Expected to finish
2022-07-01
Last updated by the study team
2023-09-18

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.