NCT04854850

Apollo Device for Fatigue in Systemic Sclerosis

Completed NA Results posted Last updated 2 April 2025

What this trial tests

NA trial testing Apollo in Systemic Sclerosis in 25 participants. Completed in 15 March 2023.

Timeline

7 July 2020

Primary endpoint
31 December 2022

15 March 2023

Quick facts

Lead sponsor	Robyn T. Domsic, MD, MPH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	7 July 2020
Primary completion	31 December 2022
Estimated completion	15 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Apollo

Conditions studied

• Systemic Sclerosis — all drugs for Systemic Sclerosis →
• Fatigue — all drugs for Fatigue →
• Raynaud Phenomenon — all drugs for Raynaud Phenomenon →

Sponsor

Robyn T. Domsic, MD, MPH

Who can join

18 and older, any sex, with Systemic Sclerosis or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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 from baseline at 4 weeks

Group	Value	95% CI
Apollo (Open-label)	-7.0	± 1.6

Baseline

Group	Value	95% CI
Apollo (Open-label)	62.5	± 5.7

Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline Secondary · Change in HAQ-D1/SHAQ from baseline to 4 weeks

The HAQ-D1/SHAQ is a patient-reported outcome of functional ability. It is a continuous scale with a results range of 0-3, with 0 meaning no disability and 3 meaning very severe disability.

Group	Value	95% CI
Apollo (Open-label)	0.12	± 0.05

Change in Total Weekly Raynaud Phenomenon Attacks Secondary · Change in total weekly attacks from baseline to 4 weeks

This is a difference in frequency count of total RP attacks per week from baseline to week 4 (end-of-study).

Group	Value	95% CI
Apollo (Open-label)	-3.4	± 1.1

Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline Secondary · From baseline to 4-week follow-up

The Raynaud Consition Score is a patient-reported outcome of a single question regarding Raynaud severity. It is a visual analog scale with a results range of 0-100. A score of 0 is no symptoms, and 100 is severe symptoms. It is recommended by OMERACT for assessment of Raynaud phenomenon.

Group	Value	95% CI
Apollo (Open-label)	-0.76	± 0.40

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association of the Apollo Wearable With Fatigue, Raynaud Phenomenon, and Quality of Life in Patients With Systemic Sclerosis: A Pilot Study.
   Hammaker K, Hu H, Laffoon M, Freno LA, et al · · 2025 · cited 1× · PMID 39617410 · DOI 10.3899/jrheum.2024-0551