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Clinical Trial NCT06939517 for Nausea is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Acupressure Wristbands for GLP-1RA Related Nausea 35 Dietary
Clinical Trial NCT06939517 is an interventional study for Nausea that is active, not recruiting. It started on February 1, 2024 with plans to enroll 35 participants. Led by Florencia Ziemke, it is expected to complete by April 13, 2025. The latest data from ClinicalTrials.gov was last updated on April 23, 2025.
Brief Summary
Nausea is a common side effect of GLP-1RA medications used for treatment of Type 2 diabetes mellitus and obesity. Current recommendations for nausea relief include the use of dietary changes and prescription anti-emetics. Acupressure wristbands Sea-Band are FDA cleared for nausea relief in other indications such as motion sickness, morning sickness in pregnancy, post-operative nausea, chemotherapy associated nausea. ...Show More
Detailed Description
Nausea is the most commonly reported side effect of the class of drugs collectively known as glucagon like peptide-1 receptor agonists (GLP-1RA). GLP-1RAs are FDA approved to treat Type 2 diabetes mellitus (T2DM) and Obesity. Sea-Band is an FDA-cleared set of drug-free elastic wristbands used for nausea relief in several indications including motion sickness, morning sickness in pregnancy, post-operative nausea, chem...Show More
Official Title
Antiemetic Effect of Acupressure Wristbands for GLP-1RA Related Nausea
Conditions
NauseaOther Study IDs
- STU25020070_evexiamed
NCT ID Number
Start Date (Actual)
2024-02-01
Last Update Posted
2025-04-23
Completion Date (Estimated)
2025-04-13
Enrollment (Estimated)
35
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
nausea relief
acupressure wristbands
glp-1 medication
obesity
acupressure wristbands
glp-1 medication
obesity
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAcupressure wristband Study arm using acupressure wristband for nausea relief associated to GLP-1 | SeaBand Drug-free, reusable Acupressure elastic wristbands applied to bilateral wrists for nausea relief |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Nausea relief | Participants will be asked to apply the wristbands at the onset of nausea, and record each nausea episode using a tracker. Weekly touch points with the study team will review their number of nausea episodes, and if nausea relief was obtained. | Nausea relief with use of wristbands for every recorded episode, reviewed weekly, for a total of four weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time to onset of relief | Participants will be asked to apply the wristbands at the onset of nausea, and record each nausea episode, confirm use of wristbands, and if time to relief was under five minutes using a tracker. Weekly touch points with the study team will review their nausea episodes. If relief was obtained, time to relief will be assessed as under or over five minutes. | Time to nausea relief with use of wristbands for every recorded episode, reviewed weekly, for a total of four weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adults taking GLp-1RA with nausea
- Adults on GLP-1RA without nausea
- Uncontrolled GERD
- Hx of Gastroparesis
- Other nausea related conditions such as vertigo
- History of chronic use of antiemetic medication for other reasons
Florencia ZiemkeStudy Responsible Party
Florencia Ziemke, Sponsor-Investigator, Founder, Medical Director, Evexia Medical
No contact data.
1 Study Locations in 1 Countries
Florida
Evexia Medical, Jupiter, Florida, 33458, United States