Systemic Sclerosis (SSc)ASScERT-QoLNCT06675344
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
A study testing Apollo Neuro Device in people with Systemic Sclerosis (SSc), run by Robyn T. Domsic, MD, MPH at 4 sites in United States.
Trial summary
The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Apollo Neuro Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Jan 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Ability to provide written informed consent,
- Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
- Baseline score ≥55 on the FACIT-Fatigue scale,
- Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
- Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, 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.
Who cannot join
- History of sympathectomy or stellate ganglion block
- History of Botox injections to the digits within the last 3 months
- Diabetes mellitus
- Major surgery within 8 weeks
- Hospitalization for any reason within four weeks of the study baseline visit
- Active malignancy
Show all 12Show fewer
- Pregnant or breastfeeding women,
- End-stage renal disease (estimated glomerular filtration rate < 15 mL/min/1.73m2) or on dialysis,
- Hepatic insufficiency as defined by function worse than Child-Pugh Class B
- Medication exclusions:
- actively prescribed standing doses of beta-blockers,
- actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Muhammad Hussain, muhammhu@med.umich.edu
Dinesh Khanna, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Sarah Gleason, sarah.wood@vumc.edu
Tracy Frech, MD MS
- Recruiting
DelRicht Research Center
New Orleans, Louisiana, 70115
Emily Krambeck, ekrambeck@delricht.com
Lesley Saketkoo, MD MPH
- Recruiting
University of Pittsburgh and UPMC Scleroderma Center
Pittsburgh, Pennsylvania, 15213
Maureen Laffoon, BS, 412-648-7871, laffoonm@pitt.edu
Bailey Gibson, MPH, 412-647-6700, BIG36@pitt.edu
About this study
Official title: A Randomized, Double-blind, Clinical Trial of the Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life (ASScERT-QoL)
The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.
Read the detailed description
Systemic sclerosis (SSc) is a multisystem autoimmune disease that is characterized by progressive vasculopathy, excessive fibrosis, and immune system activation. Fatigue in SSc is common and greatly impacts quality of life: The prevalence of fatigue in SSc patients is significantly higher than the general population. Raynaud phenomenon (RP) in SSc is not only the most common SSc manifestation, affecting nearly all but is often the earliest SSc symptom. SSc-RP is the highest ranked SSc-related symptom affecting quality of life, and is a major cause of SSc-related morbidity. There are currently no approved medications to treat RP, SSc-associated RP phenomenon or fatigue in SSc. Thus, a non-pharmacologic intervention has the potential to provide SSc patients with a new treatment modality without common limiting side effects, and access. The Apollo wearable provides transcutaneous vibratory stimulation, and can be worn on the wrist or ankle.
Goal: To recruit 160 SSc patient participants into this randomized, sham-device controlled clinical trial. Patients will be randomized 1:1 to receive the Apollo vs. sham wearable, which they will wear daily for 6 weeks.
Outcome measures focus on quality-of-life.
.
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- Apollo Neuro Device, Sham device
- Keywords
- Scleroderma, Raynaud Phenomenon, fatigue
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Raynaud Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo Neuro DeviceDevice
The Apollo Neuro wearable device is an Apple Watch-sized wearable device that delivers vibration at set frequencies , termed transcutaneous vibratory stimulation, or TVS. These low volume sound waves feel like a soothing touch to the skin (TVS) and activate touch receptors. Apollo is controlled via smartphone and worn on the wrist or ankle. The Apollo is fitted with an adjustable band, made of a durable neoprene material with polyester overlays. Participants are asked to wear it daily for a minimum time period for 6 weeks. Users can choose from different modes of vibration, with some being energizing, others relaxing.
Sham deviceDevice
The Apollo Neuro is an Apple Watch-sized wearable device that delivers vibration, termed transcutaneous vibratory stimulation, or TVS. The sham device is identical in appearance to the active intervention, but provides a lower frequency vibration that has no known therapeutic benefit.
| Study group | Role | What they receive |
|---|---|---|
| Apollo Neuro Device | Experimental | Apollo Neuro Device Receives: Device: Apollo Neuro Device |
| Sham Device | Sham comparator | Study participants will be randomized 1:1 (Apollo Neuro device : Sham device) Devices are identical; however, the sham device will be set to a frequency that has no therapeutic benefits. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue
The PROMIS® (Patient-Reported Outcomes Measurement Information System) SF v1.0 Fatigue 13a scale. This is a13-item, patient reported measure of an individual's level of fatigue during their usual daily activities over the past week. The raw score is converted to a T-score for analysis with 50 for the mean and a standard deviation of 10.
Measured: Baseline, 6 Weeks
Change in average weekly Raynaud attacks
Average number of weekly Raynaud attacks. Over a period of one week, patients will record their Raynaud phenomenon (RP) attack frequency via a smartphone app. The Raynaud app is usable on both Apple iPhones and Android phones.
Measured: Baseline, 6 Weeks
Secondary outcomes (9)
Change in quality of life
The EuroQol (EQ)-5D-5L will be used. The quality-of-life assessment instrument has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a patient global assessment visual analog scale (VAS). In the EQ-5D-5L each dimension is ranked on 5 levels of severity. Full health is a score of 1 and values below zero are regarded as a state worse than death.
Measured: baseline up to week 6
Change in Raynaud phenomenon symptom severity
The ASRAP (Assessment of Scleroderma-associated RAynaud's Phenomenon) Questionnaire Short form is a 10-item patient self-report questionnaire regarding symptoms over the last week. Raw scores are converted to T-score with a median of 50.
Measured: baseline to week 6
Change in the Raynaud Condition Score
The Raynaud Condition 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: baseline to week 6
Change Sleep
PROMIS® Sleep disturbance short form 4a will be used. This 4-item questionnaire uses a 5-point Likert scale for responses, inquiring about symptoms over the last week. Raw scores are converted to T-scores, with a mean of 50 and SD of 10.
Measured: change from baseline to week 6
Change in pain
We will use the PROMIS pain interference (v1.1- Short Form 4a) questionnaire which poses 4 questions regarding the last week of pain symptoms. Responses are in a 5-point likert scale from not at all to very much. Raw scores are converted to T-scores for analysis with a median of 50 and standard deviation of 10.
Measured: baseline to week 6
Change in depression
Depression as measured by the Patient Health Questionnaire (PHQ-8). These 8 questions are responded to with a Likert scale of 0(never) up to 3 (always) with a score range of 0-27.
Measured: change baseline to week 6
Change in Social Function
Captured using PROMIS Short Form v2.0 - Ability to Participate in Social Roles and Activities 4a. This is a 4-question survey, with respondents answering a 5-point likert scale from 'never' to 'always'. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10.
Measured: baseline to week 6
Change in dysautonomia symptoms
Change in dysautonomia symptoms as measured with the COMPASS-31 scale. This is a 31-question instrument which includes six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor . A higher score indicates worse autonomic function. Following appropriate weighting, this instrument provides an autonomic symptom score from 0 to 100.
Measured: baseline to week 6
Change in pain intensity
PROMIS® Numeric Rating Scale v.1.0 - Pain Intensity 1a will be used. This is a single question inquiring about pain in the last week, rating from 0 (no pain) to 10 (worst pain).
Measured: baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start6 Jan 2025
- Primary completion1 Mar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Sclerosis (SSc)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, sham device-controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robyn T. Domsic, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- 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
- NCT06675344
- Sponsor's protocol ID
- STUDY24040026
- Other IDs
- HT94252410456
- Acronym
- ASScERT-QoL
- Status last verified
- Jan 2026
- First submitted
- 30 Oct 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Requests for IPD can be obtained by emailing the PI of the study.
Publications
Yu L, Domsic RT, Saketkoo LA, Withey J, Frech TM, Herrick AL, Hummers LK, Shah AA, Denton CP, Khanna D, Pauling JD. Assessment of the Systemic Sclerosis-Associated Raynaud's Phenomenon Questionnaire: Item Bank and Short-Form Development. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1725-1734. doi: 10.1002/acr.25038. Epub 2023 Jan 30.
PubMed 36214062
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Clinical Trial of the Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life (ASScERT-QoL)
- ClinicalTrials.gov ID
- NCT06675344
- Acronym / sponsor ID
- ASScERT-QoL / STUDY24040026
- Conditions
- Systemic Sclerosis (SSc)
- Keywords
- Scleroderma, Raynaud Phenomenon, fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Robyn T. Domsic, MD, MPHUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
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 it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.
Detailed description
Systemic sclerosis (SSc) is a multisystem autoimmune disease that is characterized by progressive vasculopathy, excessive fibrosis, and immune system activation. Fatigue in SSc is common and greatly impacts quality of life: The prevalence of fatigue in SSc patients is significantly higher than the general population. Raynaud phenomenon (RP) in SSc is not only the most common SSc manifestation, affecting nearly all but is often the earliest SSc symptom. SSc-RP is the highest ranked SSc-related symptom affecting quality of life, and is a major cause of SSc-related morbidity. There are currently no approved medications to treat RP, SSc-associated RP phenomenon or fatigue in SSc. Thus, a non-pharmacologic intervention has the potential to provide SSc patients with a new treatment modality without common limiting side effects, and access. The Apollo wearable provides transcutaneous vibratory stimulation, and can be worn on the wrist or ankle.
Goal: To recruit 160 SSc patient participants into this randomized, sham-device controlled clinical trial. Patients will be randomized 1:1 to receive the Apollo vs. sham wearable, which they will wear daily for 6 weeks.
Outcome measures focus on quality-of-life.
.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, sham device-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Apollo Neuro Device | Experimental | Device: Apollo Neuro DeviceApollo Neuro Device |
| Sham Device | Sham comparator | Device: Sham deviceStudy participants will be randomized 1:1 (Apollo Neuro device : Sham device) Devices are identical; however, the sham device will be set to a frequency that has no therapeutic benefits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Ability to provide written informed consent,
- Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
- Baseline score ≥55 on the FACIT-Fatigue scale,
- Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
Key exclusion criteria (12 listed)
- History of sympathectomy or stellate ganglion block
- History of Botox injections to the digits within the last 3 months
- Diabetes mellitus
- Major surgery within 8 weeks
- Hospitalization for any reason within four weeks of the study baseline visit
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 |
|---|---|---|
| Apollo Neuro DeviceThe Apollo Neuro wearable device is an Apple Watch-sized wearable device that delivers vibration at set frequencies , termed transcutaneous vibratory stimulation, or TVS. These low volume sound waves feel like a soothing touch to the skin (TVS) and activate touch receptors. Apollo is controlled via smartphone and worn on the wrist or ankle. The Apollo is fitted with an adjustable band, made of a durable neoprene material with polyester overlays. Participants are asked to wear it daily for a minimum time period for 6 weeks. Users can choose from different modes of vibration, with some being energizing, others relaxing. | Device | Apollo Neuro Device |
| Sham deviceThe Apollo Neuro is an Apple Watch-sized wearable device that delivers vibration, termed transcutaneous vibratory stimulation, or TVS. The sham device is identical in appearance to the active intervention, but provides a lower frequency vibration that has no known therapeutic benefit. | Device | Sham Device |
Primary outcome
Change in fatigue
Time frame: Baseline, 6 Weeks
The PROMIS® (Patient-Reported Outcomes Measurement Information System) SF v1.0 Fatigue 13a scale. This is a13-item, patient reported measure of an individual's level of fatigue during their usual daily activities over the past week. The raw score is converted to a T-score for analysis with 50 for the mean and a standard deviation of 10.
Change in average weekly Raynaud attacks
Time frame: Baseline, 6 Weeks
Average number of weekly Raynaud attacks. Over a period of one week, patients will record their Raynaud phenomenon (RP) attack frequency via a smartphone app. The Raynaud app is usable on both Apple iPhones and Android phones.
9 secondary outcomes
Change in quality of life
Time frame: baseline up to week 6
Change in Raynaud phenomenon symptom severity
Time frame: baseline to week 6
Change in the Raynaud Condition Score
Time frame: baseline to week 6
Change Sleep
Time frame: change from baseline to week 6
Change in pain
Time frame: baseline to week 6
Change in depression
Time frame: change baseline to week 6
Change in Social Function
Time frame: baseline to week 6
Change in dysautonomia symptoms
Time frame: baseline to week 6
Change in pain intensity
Time frame: baseline to week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 36214062Yu L, Domsic RT, Saketkoo LA, Withey J, Frech TM, Herrick AL, Hummers LK, Shah AA, Denton CP, Khanna D, Pauling JD. Assessment of the Systemic Sclerosis-Associated Raynaud's Phenomenon Questionnaire: Item Bank and Short-Form Development. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1725-1734. doi: 10.1002/acr.25038. Epub 2023 Jan 30.
- Individual participant dataSharing planned: Yes. Requests for IPD can be obtained by emailing the PI of the study.
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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.
Robyn T Domsic, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Neuro Device in people with Systemic Sclerosis (SSc), run by Robyn T. Domsic, MD, MPH at 4 sites 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 12 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen M Laffoon, BS (412-648-7871, laffoonm@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue (time frame: Baseline, 6 Weeks). The study lists 2 primary outcomes in all. 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 NCT06675344, which also lists 1 linked publication.
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 8 Jan 2026.