Status:
COMPLETED
SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Sarcoidosis
Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fatigue is a pervasive and disabling symptom in sarcoidosis with limited treatment options. There is a significant association between heightened stress and sarcoidosis-associated fatigue. The propose...
Eligibility Criteria
Inclusion
- Sarcoidosis diagnosis based on established criteria
- ≥18 years old
- able to speak, hear, and understand English
- elevated SAF (FAS score ≥22)
- owns smartphone with current data plan
- willingness and ability to use app to engage in Breathing Awareness Meditation (BAM)
Exclusion
- history of psychotic disorder, bipolar disorder, eating disorder, narcolepsy, cancer diagnosis or treatment in past 12 months
- positive screening for potential major depression (Patient Health Questionnaire depression scale \[PHQ-8; α = .86\] score ≥10)
- untreated sleep apnea (based on home sleep study testing)
- sarcoidosis exacerbation in past 3 months requiring increase in sarcoidosis medications
- \>2 hr travel distance to medical center (to reduce likelihood of no-show for focus groups)
- active substance abuse or binge drinking (\>21 drinks/week )
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05230693
Start Date
February 23 2022
End Date
July 25 2023
Last Update
April 6 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29403