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Apollo Device for Fatigue in Systemic Sclerosis

Primary Purpose

Systemic Sclerosis, Fatigue, Raynaud Phenomenon

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Apollo

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring Systemic Sclerosis, Fatigue, Raynaud, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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

Sites / Locations

University of Pittsburgh School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apollo

Arm Description

Participants will all receive Apollo devices.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

The Median Change in the Raynaud Phenomenon Visual Analog Scale (RP-VAS) Score at 4 Weeks (End-of-study) Compared to Baseline

The RP-VAS scale measure ranges from 0-100, with 0 being no symptoms and 100 severe symptoms. Reported is the median and interquartile range of change between baseline and week 4 (end-of-study).

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.

Full Information

NCT ID

NCT04854850

First Posted

March 20, 2021

Last Updated

July 5, 2023

Sponsor

University of Pittsburgh

Collaborators

Apollo Neuroscience

1. Study Identification

Unique Protocol Identification Number

NCT04854850

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 7, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

Apollo Neuroscience

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Sclerosis, Fatigue, Raynaud Phenomenon

Keywords

Systemic Sclerosis, Fatigue, Raynaud, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open-label clinical trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apollo

Arm Type

Experimental

Arm Description

Participants will all receive Apollo devices.

Intervention Type

Device

Intervention Name(s)

Apollo

Other Intervention Name(s)

Apollo System, Tuned Vibrartory Stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline

Description

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.

Time Frame

Change in FACIT-Fatigue from baseline to 4 weeks

Secondary Outcome Measure Information:

Title

Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline

Description

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

Title

The Median Change in the Raynaud Phenomenon Visual Analog Scale (RP-VAS) Score at 4 Weeks (End-of-study) Compared to Baseline

Description

The RP-VAS scale measure ranges from 0-100, with 0 being no symptoms and 100 severe symptoms. Reported is the median and interquartile range of change between baseline and week 4 (end-of-study).

Time Frame

Change in RP-VAS from baseline to 4 weeks

Title

Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline

Description

Time Frame

From baseline to 4-week follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robyn T Domsic, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh School of Medicine

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12841303

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.

Results Reference

background

PubMed Identifier

14558055

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.

Results Reference

background

PubMed Identifier

17611983

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.

Results Reference

background

PubMed Identifier

29303706

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.

Results Reference

background

PubMed Identifier

19106163

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.

Results Reference

background

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Apollo Device for Fatigue in Systemic Sclerosis

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