RECRUITING

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

Conditions

Systemic Sclerosis (SSc)Scleroderma Raynaud Phenomenon fatigue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-01-06

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06675344

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Maureen M Laffoon, BS

CONTACT

412-648-7871

laffoonm@pitt.edu

Robyn T Domsic, MD

CONTACT

412-647-6700

rtd4@pitt.edu

Principal Investigator

Robyn T Domsic, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

UPMC Arthritis and Autoimmunity Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Robyn T. Domsic, MD, MPH

Robyn T Domsic, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-06

Study Completion Date2028-09

Study Record Updates

Study Start Date2025-01-06

Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

Scleroderma
Raynaud Phenomenon
fatigue

Additional Relevant MeSH Terms

Systemic Sclerosis (SSc)