The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life

Description

The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.

Conditions

Systemic Sclerosis (SSc)

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Study Overview

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Study Details

Study overview

The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.

A Randomized, Double-blind, Clinical Trial of the Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life (ASScERT-QoL)

The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life

Condition
Systemic Sclerosis (SSc)
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Arthritis and Autoimmunity Center, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥ 18 years
  • 2. Ability to provide written informed consent,
  • 3. Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
  • 4. Baseline score ≥55 on the FACIT-Fatigue scale,
  • 5. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
  • 6. Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, antidepressants and anxiolytic use for 4 weeks prior to baseline
  • 7. Currently owns and operates an iOS or Android smart phone regularly
  • 8. Ability to comply with the clinical visits schedule and the study-related procedures.
  • 1. History of sympathectomy or stellate ganglion block
  • 2. History of Botox injections to the digits within the last 3 months
  • 3. Diabetes mellitus
  • 4. Major surgery within 8 weeks
  • 5. Hospitalization for any reason within four weeks of the study baseline visit
  • 6. Active malignancy
  • 7. Pregnant or breastfeeding women,
  • 8. End-stage renal disease (estimated glomerular filtration rate \< 15 mL/min/1.73m2) or on dialysis,
  • 9. Hepatic insufficiency as defined by function worse than Child-Pugh Class B
  • 10. Medication exclusions:
  • 1. actively prescribed standing doses of beta-blockers,
  • 2. actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Robyn T. Domsic, MD, MPH,

Robyn T Domsic, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2028-09