Clinical trial NCT04854850: Apollo Device for Fatigue in Systemic Sclerosis
Official title: An Open-Label Study of the Apollo Device for Fatigue in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Fatigue
Raynaud Phenomenon
Keywords: Systemic Sclerosis
Fatigue
Raynaud
Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Apollo Neuroscience
First posted: 2021-04-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label clinical trial
Primary purpose: TREATMENT

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.

Detailed description: This is a study of the commercially available Apollo Neuro Wellness Device, which is not currently a medical device.

The device 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). 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.

A total of 30-40 patients will be enrolled and followed for 1 month, with baseline data collected before using Apollo and follow-up data collected after using the device. This clinical trial is open-label, meaning that all participants will receive Apollos and no placebos will be used. All participants will be allowed to continue underlying immunosuppressive and Raynaud therapy at stable doses during the trial. Since this is a pilot study, future larger controlled trials will be necessary to clearly demonstrate drug effectiveness.

At study registration there was an oversight and we did not include the secondary outcome of number of weekly Raynaud attacks. Raynaud visual analog scale (VAS) was not a secondary outcome measure.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent
2. Men or women aged 18 years and older
3. Diagnosis of Systemic sclerosis, as defined by 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
4. Baseline T score of 45 on the PROMIS-Fatigue scale.
5. Steady daily doses and any immunosuppressive medication, vasodilators, antidepressants and anxiolytic use for 4 weeks prior to baseline.
6. Currently owns and operates an iOS or Android smart phone regularly
7. Ability to comply with the clinical visits schedule and the study-related procedures.
8. 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.

Exclusion Criteria:

1. 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.
2. Pregnant or breastfeeding women
3. 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

Primary outcomes:
measure: Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline
timeFrame: Change in FACIT-Fatigue from baseline to 4 weeks
Secondary outcomes:
measure: Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline
timeFrame: Change in HAQ-D1/SHAQ from baseline to 4 weeks
measure: Change in Total Weekly Raynaud Phenomenon Attacks
timeFrame: Change in total weekly attacks from baseline to 4 weeks
measure: Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline
timeFrame: From baseline to 4-week follow-up
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Robyn T Domsic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.