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Behavioural Intervention

Apollo Device for Scleroderma (ASScERT-QoL Trial)

N/A

Waitlist Available

Led By Robyn T Domsic, MD

Research Sponsored by Robyn T. Domsic, MD, MPH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc with a positive ANA

Must not have

Major surgery within 8 weeks

History of sympathectomy or stellate ganglion block

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks

Summary

This trial aims to test a wearable device to see if it can help systemic sclerosis patients manage their symptoms better and improve their quality of life. The study will focus on how the Apollo Neuro device may help

Who is the study for?

This trial is for individuals with Systemic Sclerosis, a condition that causes hardening and tightening of the skin. Participants should experience fatigue and Raynaud's phenomenon, which involves poor blood flow to certain parts of the body like fingers and toes.

What is being tested?

The study is testing the Apollo Neuro Device, a wearable device designed to help manage symptoms related to Systemic Sclerosis. It will be compared against a sham (fake) device to see if it can improve fatigue and Raynaud's phenomenon.

What are the potential side effects?

Since this trial involves a non-invasive wearable device, side effects are expected to be minimal. However, some participants may experience discomfort or skin irritation from wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with systemic sclerosis and have a positive ANA test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 8 weeks.

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I have had a sympathectomy or stellate ganglion block.

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I have not had Botox injections in my fingers in the last 3 months.

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I have diabetes.

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I currently have cancer.

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I have severe kidney disease or am on dialysis.

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I am not currently taking beta-blockers, sedatives, opioids, benzodiazepines, or antipsychotics.

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My liver function is better than or equal to Child-Pugh Class B.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in average weekly Raynaud attacks

Change in fatigue

Secondary study objectives

Change Sleep

Change in Raynaud phenomenon symptom severity

Change in Social Function

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Apollo Neuro DeviceExperimental Treatment1 Intervention

Apollo Neuro Device

Group II: Sham DevicePlacebo Group1 Intervention

Study participants will be randomized 1:1 (Apollo Neuro device : Sham device) Devices are identical; however, the sham device will be set to a frequency that has no therapeutic benefits.

0 / 10Eligibility criteria met