Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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, chemotherapy associated nausea in persons ages 3 years old and up. The elastic wristbands have a plastic skin facing knob that apples pressure to an acupressure point called pericardium 6 (P6) located below the crease of the wrist. We hypothesize that Sea-Band can alleviate nausea in persons taking GLP-1RA. Participants on GLP-1RA medication with nausea were offered a set of Acupressure wristbands, and followed for four weeks. Weekly touch points assessed the response to nausea relief of the bands. Eligibility for the study included Adults taking GLP-1RA experiencing nausea.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupressure wristband | Experimental | Study arm using acupressure wristband for nausea relief associated to GLP-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeaBand | Device | Drug-free, reusable Acupressure elastic wristbands applied to bilateral wrists for nausea relief |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evexia Medical | Jupiter | Florida | 33458 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009325 | Nausea |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
Not provided
Not provided
prospective interventional study of four weeks duration evaluating the antiemetic effect of wristbands for nausea related to GLP-1RA medication.
Not provided
Not provided
Not provided
Not provided
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |