Fatigue, Raynaud Phenomenon, Systemic Sclerosis
Conditions
Keywords
Systemic Sclerosis, Fatigue, Raynaud, Pain
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.
Interventions
DEVICEApollo
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.
Sponsors
Apollo Neuroscience
Robyn T. Domsic, MD, MPH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline | 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. |
| Change in Total Weekly Raynaud Phenomenon Attacks | 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). |
| Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the University of Pittsburgh Scleroderma clinic
Participants by arm
| Arm | Count |
|---|---|
| Apollo Participants will all receive Apollo devices. 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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Apollo |
|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 13.2 |
| Diffuse Skin Involvement | 9 Participants |
| History of Digital Ulcers | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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.
Time frame: Change in FACIT-Fatigue from baseline to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Apollo (Open-label) | Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline | Change from baseline at 4 weeks | -7.0 T-score | Standard Deviation 1.6 |
| Apollo (Open-label) | Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline | Baseline | 62.5 T-score | Standard Deviation 5.7 |
p-value: <0.001t-test, 2 sided
Secondary
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.
Time frame: Change in HAQ-D1/SHAQ from baseline to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apollo (Open-label) | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline | 0.12 score on a scale | Standard Deviation 0.05 |
Secondary
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.
Time frame: From baseline to 4-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apollo (Open-label) | Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline | -0.76 units on a scale | Standard Deviation 0.4 |
Secondary
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).
Time frame: Change in total weekly attacks from baseline to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apollo (Open-label) | Change in Total Weekly Raynaud Phenomenon Attacks | -3.4 attacks | Standard Deviation 1.1 |