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Wearable Device

Apollo Device for Breast Cancer

N/A
Recruiting
Led By Margaret Q Rosenzweig
Research Sponsored by Margaret Quinn Rosenzweig
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic breast cancer diagnosis
Fatigue score of 4 or greater at last clinic visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights

Study Summary

This trial will study whether the Apollo wearable device, similar to a FitBit, can help with symptoms of fatigue and pain in patients with Metastatic Breast Cancer.

Who is the study for?
This trial is for individuals with Metastatic Breast Cancer (MBC) who experience significant fatigue. Participants must have had a fatigue score of 4 or higher at their last clinic visit, be able to read and understand English, and not be on medications for serious mental illness or beta blockers.Check my eligibility
What is being tested?
The Apollo Armband, a wearable device that emits vibrations similar to a FitBit, is being tested in this study. The goal is to see if it can reduce symptoms of fatigue and pain in patients with MBC through self-reported surveys and medical chart reviews.See study design
What are the potential side effects?
Since the Apollo Armband uses vibrations, potential side effects may include discomfort where the armband touches the skin or an allergic reaction to its materials. However, specific side effects are not detailed as it's non-invasive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer has spread to other parts of my body.
Select...
I reported a fatigue level of 4 or higher at my last clinic visit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Fatigue (FACT-F)
Change in Fatigue (PROMIS-Fatigue)
Secondary outcome measures
Degree of Pain
Health Related quality of life (HRQOL)
Hospital Anxiety and Depression Scale (HADS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Apollo ArmbandExperimental Treatment1 Intervention
Armband that can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain.

Find a Location

Who is running the clinical trial?

Margaret Quinn RosenzweigLead Sponsor
Apollo Neuroscience, Inc.Industry Sponsor
4 Previous Clinical Trials
6,700 Total Patients Enrolled
Margaret Q RosenzweigPrincipal InvestigatorUniversity of Pittsburgh School of Nursing

Media Library

Apollo Armband (Wearable Device) Clinical Trial Eligibility Overview. Trial Name: NCT04983342 — N/A
Fatigue Research Study Groups: Apollo Armband
Fatigue Clinical Trial 2023: Apollo Armband Highlights & Side Effects. Trial Name: NCT04983342 — N/A
Apollo Armband (Wearable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04983342 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I qualify to be involved in this scientific experiment?

"This clinical trial is looking to recruit 30 participants between 18 and 100 years old who suffer from fatigue. In order for patients to be eligible, they must have a diagnosis of metastatic breast cancer with a fatigue score of 4 or higher at their last clinic visit."

Answered by AI

What is the present capacity for participants in this experiment?

"Affirmative. Evidence on clinicaltrials.gov reveals that this trial, first posted in February 2021 is actively recruiting patients to its single location. Thus far, 30 participants have joined the study with a recent update date of January 27th 2022."

Answered by AI

Does this research endeavor include individuals over the age of twenty?

"This trial necessitates that any participating patient is between 18 and 100 years old. Additionally, there are separate trials for those under 18 (76) and over 65 (2367)."

Answered by AI

Is the research team accepting new participants for this experiment?

"Affirmative. Perusal of clinicaltrials.gov indicates that this medical experiment is currently enrolling participants - it was first published on February 1st, 2021 and underwent its most recent update on January 27th 2022. 30 patients are needed at a single site for the study to be completed successfully."

Answered by AI

What are the fundamental aims of this clinical experiment?

"This trial, which has an 8 week time frame and utilises the PROMIS system to measure outcomes, aims to ascertain changes in fatigue. Secondary objectives include gauging levels of pain intensity (3-15) and interference with important aspects of life (6-30), determining usage patterns for analgesic medications, and calculating overall sleep quality scores from "very poor" through to "very good" (8-45)."

Answered by AI
~10 spots leftby Dec 2025