Acupressure Wristbands for GLP-1RA Related Nausea

NCT06939517 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STU25020070_evexiamed
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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. We hypothesized that acupressure wristbands could alleviate nausea in persons taking GLP-1RA.

Conditions

Nausea

Keywords

nausea relief; acupressure wristbands; glp-1 medication; obesity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to onset of relief

  Time to nausea relief with use of wristbands for every recorded episode, reviewed weekly, for a total of four weeks

Study Arms (1)

Acupressure wristband

EXPERIMENTAL

Study arm using acupressure wristband for nausea relief associated to GLP-1

Device: SeaBand

Interventions

SeaBand DEVICE

Drug-free, reusable Acupressure elastic wristbands applied to bilateral wrists for nausea relief

Acupressure wristband

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults taking GLp-1RA with nausea

You may not qualify if:

• 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

Sponsors & Collaborators

• Florencia Ziemke: lead

Study Sites (1)

Evexia Medical

Jupiter, Florida, 33458, United States

Location

MeSH Terms

Conditions

Nausea; Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Founder, Medical Director

Model Details: prospective interventional study of four weeks duration evaluating the antiemetic effect of wristbands for nausea related to GLP-1RA medication.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 23, 2025
• Study Start: February 1, 2024
• Primary Completion: March 13, 2025
• Study Completion: April 13, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)