The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Robyn T. Domsic, MD, MPH
Study ID
NCT06675344
Status
Recruiting
Apply to this trial

Conditions

  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apollo Neuro Device — DEVICE
    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 device — DEVICE
    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 Details

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.

Key Dates

Start date
Jan 6, 2025
Status verified
Jan 2026
Primary completion
Mar 1, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Apollo Neuro Device
    Apollo Neuro Device
  • Sham Comparator: Sham Device
    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.

Primary Outcome Measure

Change in fatigue [ Time Frame: Baseline, 6 Weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
DelRicht Research CenterNew OrleansLouisiana70115
Emily Krambeck
[email protected]
Lesley Saketkoo, MD MPH (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Muhammad Hussain
[email protected]
Dinesh Khanna, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh and UPMC Scleroderma CenterPittsburghPennsylvania15213
Maureen Laffoon, BS
[email protected]
412-648-7871
Bailey Gibson, MPH
[email protected]
412-647-6700
Robyn T Domsic, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Sarah Gleason
[email protected]
Tracy Frech, MD MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Orleans, LA

By research site
DelRicht Research Center· New Orleans, LAUniversity of Michigan· Ann Arbor, MIUniversity of Pittsburgh and UPMC Scleroderma Center· Pittsburgh, PAVanderbilt University Medical Center· Nashville, TN

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