Pain in Long COVID-19: The Role of Sleep

Long COVID Clinical Trial

Official title:

Pain in PASC - The Role of Sleep Disturbances

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606211
• Other study ID #: 2022P-000257
• Status: Recruiting
• Start date: October 4, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: Monika Haack
• Phone: 6176675234
• Email: mhaack[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• 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

Related Conditions & MeSH terms

• Long COVID

Intervention

Other:
• No intervention
Observational, no intervention

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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