Deep Venous Thrombosis of Deep Femoral VeinNCT06042686
Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems
A study testing RF Health MAC Device in people with Deep Venous Thrombosis of Deep Femoral Vein, run by University of Massachusetts, Amherst at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Venous Thrombosis of Deep Femoral Vein
- What is being tested?
- RF Health MAC Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult participants age 50-75
- BMI 18-39
Who cannot join
- BMI or age outside of the inclusion criteria limits
- stomach-sleepers
- uncontrolled asthma
- surgery within the past 6 weeks
- history of venous thrombosis within the past 12 months
- abnormalities of the lower extremities, including edema, deformity which does not allow for proper fit of the external mechanical compression devices
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- skin breakdown of any kind
- severe peripheral neuropathy
- skin grafting within the last 3 months, cellulitis or dermatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Amherst
Amherst, Massachusetts, 01003
About this study
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.
Read the detailed description
Recruitment
- Respondents are solicited via social media/local flyer campaigns (see attached flyers), or word of mouth (see Recruitment via Word of Mouth) to complete a brief, electronic pre-screening survey powered by REDCap software, or to set up a phone call to review study eligibility if preferred.
- Recruiter responds to eligible or interested Respondents as described in Recruitment Attachments (i.e., Recruitment Email Script).
- Recruiter coordinates a phone interview with interested and eligible Respondents to confirm eligibility criteria and review the Informed Consent Form with the Respondent in real time over the phone, while the Respondent follows along with a secure REDCap Informed Consent survey to capture an electronic signature.
- Consenting Participants will submit the Informed Consent form electronically, receive a .pdf copy of their completed (signed) Informed Consent form, and be prompted to complete a subsequent electronic Contact Information Questionnaire, which will only be accessible within the REDCap server by authorized study personnel, e.g. PI and Recruitment Coordinator. A electronic COVID-19 Vaccination Status Confirmation Form will also be completed at this time, including a single upload field for a digital image of the participant's vaccination card. This image will be visually inspected by the Recruiter and immediately deleted from the REDCap server.
- The Recruiter will manually assign the Participant a coded record ID and follow-up with the Participant via phone or email for tentative scheduling of equipment delivery and data collection through the full protocol. Scheduling will be confirmed with Participants in the week leading up to each transport event.
- Prior to scheduled data collection, all consenting participants will be screened in their homes for undetected deep vein thrombosis using mobile doppler ultrasound while following all COVID-19 guidelines. Any participant who screens in positive for deep vein thrombosis will be withdrawn from the study.
Study Procedures
- Once interested respondents have completed all pre-screening, informed consent process will be completed. The voluntary nature of the research will be stressed, participants will have the opportunity to have all of their questions answered, and they will be reminded that they can withdraw their consent at any time.
- Once consent has been executed and subsequent enrollment forms completed, participants will be scheduled for their deep vein thrombosis screening, their sleep monitoring data collection nights, and their equipment delivery.
- Participants will then be randomized to receive either the Kendall® or RF Health System on data collection night 1
- Due to the COVID-19 outbreak, UMass researchers will transport the all study equipment to and from the participants residences using all COVID-19 guidelines and will disinfect all materials at the UMass Sleep Monitoring Laboratory between uses.
- To ensure high-quality data acquisition, researchers will video conference with participants at prescheduled times, approximately 1-hour prior to participants typical bedtime to provide real-time, remote guidance for proper self-application of the Sleep Profiler headset, Kendall and RF Health System. The first of these sessions will take place shortly after the scheduled deep vein thrombosis screening session. The teleconferencing will take not more of the participant's time than a typical, in-person application.
- At the conclusion of their first overnight sleep profiler data collection (via Sleep Profiler headset, see attached Technical Manual) while using one of the leg compression devices, participants will be asked to complete their self-report measures in the following order: PROMIS Sleep Disturbance Form 6a, Comfort Rating Scale, Environmental Comfort Scale, System Usability Scale, and Task Load Index.
- There will be at least one night without any devices between data collection nights 1 \& 2.
- All study procedures will be repeated on data collection overnight 2 using the other external compression device.
- Once data collection for night 2 has been completed, all participants will be asked if they have any further questions and all questions will be addressed.
- Being tested
- RF Health MAC Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF Health MAC DeviceDevice
Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) 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.
| Study group | Role | What they receive |
|---|---|---|
| Repeated measures | Other | Using a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) 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. Receives: Device: RF Health MAC Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the impact of external mechanical compression on overall sleep.
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.
Measured: 4 Months
Compare the comfort associated with mechanical compression between the two devices.
After each night of sleep, participants will provide their self-report on comfort using the Comfort Rating Scale.
Measured: 4 months
Compare the noise associated with mechanical compression between the two devices.
After each night of sleep, participants will provide their self-report on noise using the Environmental Comfort Scale.
Measured: 4 months
Compare the usability associated with mechanical compression between the two devices.
After each night of sleep, participants will provide their self-report on usability using the System Usability Scale.
Measured: 4 months
Compare the perceived sleep disturbance associated with mechanical compression between the two devices.
After each night of sleep, participants will provide their self-report on sleep disturbance using the PROMIS Sleep Disturbance: Short Form 8a.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Dec 2021
- Primary completion2 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous Thrombosis of Deep Femoral VeinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures study design where each participant gets both devices on different nights in random order
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042686
- Sponsor's protocol ID
- 2096
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thrombosis Prevention and Sleep Quality: A Comparison of the Kendall and the Recovery Health MAC Systems
- ClinicalTrials.gov ID
- NCT06042686
- Acronym / sponsor ID
- 2096
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recruitment
- Respondents are solicited via social media/local flyer campaigns (see attached flyers), or word of mouth (see Recruitment via Word of Mouth) to complete a brief, electronic pre-screening survey powered by REDCap software, or to set up a phone call to review study eligibility if preferred.
- Recruiter responds to eligible or interested Respondents as described in Recruitment Attachments (i.e., Recruitment Email Script).
- Recruiter coordinates a phone interview with interested and eligible Respondents to confirm eligibility criteria and review the Informed Consent Form with the Respondent in real time over the phone, while the Respondent follows along with a secure REDCap Informed Consent survey to capture an electronic signature.
- Consenting Participants will submit the Informed Consent form electronically, receive a .pdf copy of their completed (signed) Informed Consent form, and be prompted to complete a subsequent electronic Contact Information Questionnaire, which will only be accessible within the REDCap server by authorized study personnel, e.g. PI and Recruitment Coordinator. A electronic COVID-19 Vaccination Status Confirmation Form will also be completed at this time, including a single upload field for a digital image of the participant's vaccination card. This image will be visually inspected by the Recruiter and immediately deleted from the REDCap server.
- The Recruiter will manually assign the Participant a coded record ID and follow-up with the Participant via phone or email for tentative scheduling of equipment delivery and data collection through the full protocol. Scheduling will be confirmed with Participants in the week leading up to each transport event.
- Prior to scheduled data collection, all consenting participants will be screened in their homes for undetected deep vein thrombosis using mobile doppler ultrasound while following all COVID-19 guidelines. Any participant who screens in positive for deep vein thrombosis will be withdrawn from the study.
Study Procedures
- Once interested respondents have completed all pre-screening, informed consent process will be completed. The voluntary nature of the research will be stressed, participants will have the opportunity to have all of their questions answered, and they will be reminded that they can withdraw their consent at any time.
- Once consent has been executed and subsequent enrollment forms completed, participants will be scheduled for their deep vein thrombosis screening, their sleep monitoring data collection nights, and their equipment delivery.
- Participants will then be randomized to receive either the Kendall® or RF Health System on data collection night 1
- Due to the COVID-19 outbreak, UMass researchers will transport the all study equipment to and from the participants residences using all COVID-19 guidelines and will disinfect all materials at the UMass Sleep Monitoring Laboratory between uses.
- To ensure high-quality data acquisition, researchers will video conference with participants at prescheduled times, approximately 1-hour prior to participants typical bedtime to provide real-time, remote guidance for proper self-application of the Sleep Profiler headset, Kendall and RF Health System. The first of these sessions will take place shortly after the scheduled deep vein thrombosis screening session. The teleconferencing will take not more of the participant's time than a typical, in-person application.
- At the conclusion of their first overnight sleep profiler data collection (via Sleep Profiler headset, see attached Technical Manual) while using one of the leg compression devices, participants will be asked to complete their self-report measures in the following order: PROMIS Sleep Disturbance Form 6a, Comfort Rating Scale, Environmental Comfort Scale, System Usability Scale, and Task Load Index.
- There will be at least one night without any devices between data collection nights 1 \& 2.
- All study procedures will be repeated on data collection overnight 2 using the other external compression device.
- Once data collection for night 2 has been completed, all participants will be asked if they have any further questions and all questions will be addressed.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures study design where each participant gets both devices on different nights in random order
| Arm | Type | Receives |
|---|---|---|
| Repeated measures | Other | Device: RF Health MAC DeviceUsing a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult participants age 50-75
- BMI 18-39
Key exclusion criteria (9 listed)
- BMI or age outside of the inclusion criteria limits
- stomach-sleepers
- uncontrolled asthma
- surgery within the past 6 weeks
- history of venous thrombosis within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF Health MAC DeviceUsing a 2-day counterbalanced, within-subject repeated-measures design, 16 participants wore two mechanical compression devices, the commonly-used Kendall SCD Express 9525 (SCD) and the novel Recovery Force Movement and Compressions Device (RF-MAC) 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. | Device | Repeated measures |
Primary outcome
Measure the impact of external mechanical compression on overall sleep.
Time frame: 4 Months
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.
Compare the comfort associated with mechanical compression between the two devices.
Time frame: 4 months
After each night of sleep, participants will provide their self-report on comfort using the Comfort Rating Scale.
Compare the noise associated with mechanical compression between the two devices.
Time frame: 4 months
After each night of sleep, participants will provide their self-report on noise using the Environmental Comfort Scale.
Compare the usability associated with mechanical compression between the two devices.
Time frame: 4 months
After each night of sleep, participants will provide their self-report on usability using the System Usability Scale.
Compare the perceived sleep disturbance associated with mechanical compression between the two devices.
Time frame: 4 months
After each night of sleep, participants will provide their self-report on sleep disturbance using the PROMIS Sleep Disturbance: Short Form 8a.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF Health MAC Device in people with Deep Venous Thrombosis of Deep Femoral Vein, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the impact of external mechanical compression on overall sleep. (time frame: 4 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.