Apollo Device for Fatigue in Systemic Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04854850
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Pittsburgh
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robyn T Domsic, MD
Principal Investigator Affiliation University of Pittsburgh
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Sclerosis, Fatigue, Raynaud Phenomenon
Additional Details

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.

Arms & Interventions

Arms

Experimental: Apollo

Participants will all receive Apollo devices.

Interventions

Device: - Apollo

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213

Site Contact

Robyn T Domsic, MD

[email protected]

412-383-8000