Apollo Device for Fatigue in Systemic Sclerosis

NCT04854850 | Completed Results DMC FDA Device

• 1 other identifier: STUDY19100104
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about the effect of Apollo (a vibrating wearable about the side of an Apple Watch) on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic sclerosis. SSc patients frequently have fatigue as a characteristic feature of their disease and fatigue negatively impacts quality of life (Haythornthwaite 2003, Richards 2003, Suarez-Almazor 2007, Basta 2017). The prevalence of fatigue among SSc patients is 75%, with 61% ranking fatigue among their top three most distressing complaints. Fatigue is also associated with poor sleep quality, greater pain and depressive symptoms (Sandusky 2009). We hypothesize that treatment with Apollo over 1 month will improve fatigue. If successful, the Apollo technology will be the first treatment option for fatigue and Raynaud's in this population.

Conditions

Systemic Sclerosis; Fatigue; Raynaud Phenomenon

Keywords

Systemic Sclerosis; Fatigue; Raynaud; Pain

Outcome Measures

Primary Outcomes (1)

• Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline

  The FACIT-Fatigue is a patient reported outcome of fatigue symptoms, with a score range of 13-65. Low scores indicate low levels of fatigue and high scores indicate high levels of fatigue. A T-score of 50 indicates the population mean with a standard deviation of 10. A lower t-score indicates less fatigue. There are no clinically relevant thresholds.

  Change in FACIT-Fatigue from baseline to 4 weeks

Secondary Outcomes (3)

• Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline

  Change in HAQ-D1/SHAQ from baseline to 4 weeks

• Change in Total Weekly Raynaud Phenomenon Attacks

  Change in total weekly attacks from baseline to 4 weeks

• Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline

  From baseline to 4-week follow-up

Study Arms (1)

Apollo

EXPERIMENTAL

Participants will all receive Apollo devices.

Device: Apollo

Interventions

Apollo DEVICE

The Apollo System offers a convenient novel non-invasive, non-habit-forming solution to improve performance and recovery under stress in children and adults by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time (Siegle \& Rabin et al., under review). The gentle vibrations delivered by the Apollo System are extremely low intensity in that they are typically just barely noticeable or perceptible by the user. Additionally, the range of frequencies and intensities of the Apollo System have been safely used in numerous commercial products without adverse events reported, including sexual vibrators and massagers. 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.

Also known as: Apollo System, Tuned Vibrartory Stimulation

Apollo

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent
• Men or women aged 18 years and older
• Diagnosis of Systemic sclerosis, as defined by 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
• Baseline T score of 45 on the PROMIS-Fatigue scale.
• Steady daily doses and any immunosuppressive medication, vasodilators, 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.
• Subjects who have struggled with symptoms of SSc (specifically fatigue and Raynauds) who have not received adequate symptom relief from prior treatment attempts (treatment-resistant) will be prioritized.

You may not qualify if:

• Medical and surgical history
• Major surgery within 8 weeks prior to screening
• Participants with an active malignancy.
• End-stage renal disease with an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 (MDRD formula) or on dialysis at the screening visit
• Hepatic insufficiency as defined by the Child-Pugh criteria
• Hospitalization for any reason within four weeks of the study baseline visit.
• History of sympathectomy or stellate ganglion block
• Significant interstitial lung disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted
• Pulmonary hypertension with change in medications in the preceding four weeks
• Actively prescribed standing doses of beta-blockers.
• Actively prescribed standing doses of sedatives, hypnotics, opioids, or benzodiazepines.
• Active or unstable psychotic disorder requiring current prescriptions of standing doses of antipsychotic medications
• Active suicidal/homicidal ideation or a suicide or homicide attempt in the past year.
• Pregnant or breastfeeding women
• Other • Any other condition or therapy that would make the participant unsuitable for this study and will not allow participation for the full planned study period

Sponsors & Collaborators

• Robyn T. Domsic, MD, MPH: lead
• Apollo Neuroscience: collaborator

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

• Haythornthwaite JA, Heinberg LJ, McGuire L. Psychologic factors in scleroderma. Rheum Dis Clin North Am. 2003 May;29(2):427-39. doi: 10.1016/s0889-857x(03)00020-6.

  PMID: 12841303 BACKGROUND

• Richards HL, Herrick AL, Griffin K, Gwilliam PD, Loukes J, Fortune DG. Systemic sclerosis: patients' perceptions of their condition. Arthritis Rheum. 2003 Oct 15;49(5):689-96. doi: 10.1002/art.11385.

  PMID: 14558055 BACKGROUND

• Suarez-Almazor ME, Kallen MA, Roundtree AK, Mayes M. Disease and symptom burden in systemic sclerosis: a patient perspective. J Rheumatol. 2007 Aug;34(8):1718-26. Epub 2007 Jul 1.

  PMID: 17611983 BACKGROUND

• Basta F, Afeltra A, Margiotta DPE. Fatigue in systemic sclerosis: a systematic review. Clin Exp Rheumatol. 2018 Jul-Aug;36 Suppl 113(4):150-160. Epub 2017 Dec 15.

  PMID: 29303706 BACKGROUND

• Sandusky SB, McGuire L, Smith MT, Wigley FM, Haythornthwaite JA. Fatigue: an overlooked determinant of physical function in scleroderma. Rheumatology (Oxford). 2009 Feb;48(2):165-9. doi: 10.1093/rheumatology/ken455. Epub 2008 Dec 23.

  PMID: 19106163 BACKGROUND

• Hammaker K, Hu H, Laffoon M, Freno LA, Lafyatis R, Park Y, Domsic RT. Association of the Apollo Wearable With Fatigue, Raynaud Phenomenon, and Quality of Life in Patients With Systemic Sclerosis: A Pilot Study. J Rheumatol. 2025 Feb 1;52(2):158-164. doi: 10.3899/jrheum.2024-0551.

  PMID: 39617410 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Fatigue; Raynaud Disease; Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robyn T. Domsic
• Organization: University of Pittsburgh

rtd4@pitt.edu

412-383-8000

Study Officials

• Robyn T Domsic, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open-label clinical trial

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: April 22, 2021
• Study Start: July 7, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 15, 2023
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)