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

NCT06675344 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY24040026HT94252410456
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief Summary

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)

Keywords

Scleroderma; Raynaud Phenomenon; fatigue

Outcome Measures

Primary Outcomes (2)

• Change in fatigue

  The PROMIS® (Patient-Reported Outcomes Measurement Information System) SF v1.0 Fatigue 13a scale. This is a13-item, patient reported measure of an individual's level of fatigue during their usual daily activities over the past week. The raw score is converted to a T-score for analysis with 50 for the mean and a standard deviation of 10.

  Baseline, 6 Weeks

• Change in average weekly Raynaud attacks

  Average number of weekly Raynaud attacks. Over a period of one week, patients will record their Raynaud phenomenon (RP) attack frequency via a smartphone app. The Raynaud app is usable on both Apple iPhones and Android phones.

  Baseline, 6 Weeks

Secondary Outcomes (9)

• Change in quality of life

  baseline up to week 6

• Change in Raynaud phenomenon symptom severity

  baseline to week 6

• Change in the Raynaud Condition Score

  baseline to week 6

• Change Sleep

  change from baseline to week 6

• Change in pain

  baseline to week 6

Study Arms (2)

Apollo Neuro Device

EXPERIMENTAL

Apollo Neuro Device

Device: Apollo Neuro Device

Sham Device

SHAM COMPARATOR

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.

Device: Sham device

Interventions

Apollo Neuro Device DEVICE

The Apollo Neuro wearable device is an Apple Watch-sized wearable device that delivers vibration at set frequencies , termed transcutaneous vibratory stimulation, or TVS. These low volume sound waves feel like a soothing touch to the skin (TVS) and activate touch receptors. Apollo is controlled via smartphone and worn on the wrist or ankle. The Apollo is fitted with an adjustable band, made of a durable neoprene material with polyester overlays. Participants are asked to wear it daily for a minimum time period for 6 weeks. Users can choose from different modes of vibration, with some being energizing, others relaxing.

Apollo Neuro Device

Sham device DEVICE

The Apollo Neuro is an Apple Watch-sized wearable device that delivers vibration, termed transcutaneous vibratory stimulation, or TVS. The sham device is identical in appearance to the active intervention, but provides a lower frequency vibration that has no known therapeutic benefit.

Sham Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Ability to provide written informed consent,
• Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
• Baseline score ≥55 on the FACIT-Fatigue scale,
• Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
• 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
• Currently owns and operates an iOS or Android smart phone regularly
• Ability to comply with the clinical visits schedule and the study-related procedures.

You may not qualify if:

• History of sympathectomy or stellate ganglion block
• History of Botox injections to the digits within the last 3 months
• Diabetes mellitus
• Major surgery within 8 weeks
• Hospitalization for any reason within four weeks of the study baseline visit
• Active malignancy
• Pregnant or breastfeeding women,
• End-stage renal disease (estimated glomerular filtration rate \< 15 mL/min/1.73m2) or on dialysis,
• Hepatic insufficiency as defined by function worse than Child-Pugh Class B
• actively prescribed standing doses of beta-blockers,
• actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.

Sponsors & Collaborators

• Robyn T. Domsic, MD, MPH: lead
• United States Department of Defense: collaborator

Study Sites (4)

DelRicht Research Center

New Orleans, Louisiana, 70115, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

University of Pittsburgh and UPMC Scleroderma Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (1)

• Yu L, Domsic RT, Saketkoo LA, Withey J, Frech TM, Herrick AL, Hummers LK, Shah AA, Denton CP, Khanna D, Pauling JD. Assessment of the Systemic Sclerosis-Associated Raynaud's Phenomenon Questionnaire: Item Bank and Short-Form Development. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1725-1734. doi: 10.1002/acr.25038. Epub 2023 Jan 30.

  PMID: 36214062 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Raynaud Disease; Fatigue

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robyn T Domsic, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen M Laffoon, BS

CONTACT

412-648-7871; laffoonm@pitt.edu

Robyn T Domsic, MD

CONTACT

412-647-6700; rtd4@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: This is a randomized, double-blind, sham device-controlled trial.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 5, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available after the study has been completed and published
• Access Criteria: We will comply with the CDMRP policy for data sharing, while also complying with all pertinent local, state, and federal regulations. All individuals requesting the data sets will be required to enter into a data share agreement that: (1) acknowledges that the data will be stripped of any identifying markers, (2) acknowledge the data will only be utilized for research purposes, and (3) assure that the requesting investigator will destroy the raw data when the research is completed.

Locations

US (4)