Long COVID Clinical Trial
Official title:
Pain in PASC - The Role of Sleep Disturbances
NCT number | NCT05606211 |
Other study ID # | 2022P-000257 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 4, 2022 |
Est. completion date | June 30, 2024 |
Pain is among the most frequently reported symptoms in Long COVID, along with sleep disturbances, fatigue, and cognitive impairments. Sleep plays a critical role in maintaining a pain-free state. The goal of this study is to characterize the type and severity of pain in Long COVID, to characterize sleep and sleep disturbances in Long COVID, and to understand the role of sleep in the development and persistence of pain symptoms in Long COVID.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Females and males >18 years - Confirmed history of SARS-CoV-2 infection Exclusion Criteria - History of chronic pain prior to SARS-CoV-2 infection - Raynaud syndrome - Pregnant/nursing |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain reporting | Daily pain severity reporting on rating scale from 0 to 10 (greater values indicate greater pain) | 14 days | |
Primary | Pain sensitivity | Pain thresholds to mechanical and temperature stimuli measured in kPa (pressure) and Celsius (heat). Lower values indicate lower pain thresholds. | 1 day | |
Primary | Central pain modulation | Capacity of the CNS to modulate pain | 1 day | |
Primary | Wearable based sleep characteristics | Estimation of sleep duration, fragmentation, regularity based on actigraphy | 2 weeks | |
Primary | PSG based sleep characteristics | Sleep stages and architecture based on PSG | 1 day |
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