Trial Outcomes & Findings for Apollo Device for Fatigue in Systemic Sclerosis (NCT NCT04854850)

Last Updated: 2025-04-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Change in FACIT-Fatigue from baseline to 4 weeks

Results posted on

2025-04-02

Participant Flow

Patients were recruited from the University of Pittsburgh Scleroderma clinic

Participant milestones

Participant milestones
Measure	Apollo (Open-label) 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.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant did not have exam history available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apollo n=25 Participants 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.
Age, Continuous	59.4 years STANDARD_DEVIATION 13.2 • n=25 Participants
Sex: Female, Male Female	22 Participants n=25 Participants
Sex: Female, Male Male	3 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	1 Participants n=25 Participants
Race (NIH/OMB) White	23 Participants n=25 Participants
Race (NIH/OMB) More than one race	1 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Region of Enrollment United States	25 participants n=25 Participants
Diffuse Skin Involvement	9 Participants n=25 Participants
History of Digital Ulcers	13 Participants n=24 Participants • One participant did not have exam history available.

PRIMARY outcome

Timeframe: Change in FACIT-Fatigue from baseline to 4 weeks

Outcome measures

Outcome measures
Measure	Apollo (Open-label) n=25 Participants 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.
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Apollo (Open-label) n=25 Participants 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.
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 outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Apollo (Open-label) n=25 Participants 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.
Change in Total Weekly Raynaud Phenomenon Attacks	-3.4 attacks Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Apollo (Open-label) n=25 Participants 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.
Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline	-0.76 units on a scale Standard Deviation 0.40

Adverse Events

Apollo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robyn T. Domsic

University of Pittsburgh

Phone: 412-383-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place