Systemic SclerosisNCT04854850
Apollo Device for Fatigue in Systemic Sclerosis
A study testing Apollo in people with Systemic Sclerosis and Fatigue, run by Robyn T. Domsic, MD, MPH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Fatigue, Raynaud Phenomenon
- What is being tested?
- Apollo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Open-Label Study of the Apollo Device for Fatigue in Systemic Sclerosis
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.
Read the 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.
- Conditions
- Systemic Sclerosis, Fatigue, Raynaud Phenomenon
- Being tested
- Apollo
- Keywords
- Systemic Sclerosis, Fatigue, Raynaud, Pain
- Medical subject headings
- Scleroderma, Systemic, Fatigue, Raynaud Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApolloDevice
Also called Apollo System, Tuned Vibrartory Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Apollo | Experimental | Participants will all receive Apollo devices. Receives: Device: Apollo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Change in HAQ-D1/SHAQ from baseline to 4 weeks
Change in Total Weekly Raynaud Phenomenon Attacks
This is a difference in frequency count of total RP attacks per week from baseline to week 4 (end-of-study).
Measured: 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
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.
Measured: From baseline to 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start7 Jul 2020
- Primary completion31 Dec 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robyn T. Domsic, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Neuroscience
- Responsible party
- Sponsor-investigator, Robyn T. Domsic, MD, MPH, University of Pittsburgh
- Investigators
- Robyn T Domsic, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854850
- Sponsor's protocol ID
- STUDY19100104
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2021
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 12841303Richards 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.
PubMed 14558055Suarez-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.
PubMed 17611983Basta 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.
PubMed 29303706Sandusky 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.
PubMed 19106163Hammaker 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.
PubMed 39617410
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Apollo Device for Fatigue in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04854850
- Acronym / sponsor ID
- STUDY19100104
- Conditions
- Systemic Sclerosis, Fatigue, Raynaud Phenomenon
- Keywords
- Systemic Sclerosis, Fatigue, Raynaud, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Robyn T. Domsic, MD, MPHUniversity, hospital or other
- Collaborators
- Apollo Neuroscience
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Apollo | Experimental | Device: ApolloParticipants will all receive Apollo devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- Medical and surgical history
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApolloAlso: Apollo System, Tuned Vibrartory StimulationThe 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. | Device | Apollo |
Primary outcome
Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline
Time frame: 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.
3 secondary outcomes
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline
Time frame: Change in HAQ-D1/SHAQ from baseline to 4 weeks
Change in Total Weekly Raynaud Phenomenon Attacks
Time frame: 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
Time frame: From baseline to 4-week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12841303Haythornthwaite 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.
- Background: PubMed 14558055Richards 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.
- Background: PubMed 17611983Suarez-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.
- Background: PubMed 29303706Basta 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.
- Background: PubMed 19106163Sandusky 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.
- Derived from this study: PubMed 39617410Hammaker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn T Domsic, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo in people with Systemic Sclerosis and Fatigue, run by Robyn T. Domsic, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline (time frame: Change in FACIT-Fatigue from baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854850, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.