Pain in Long COVID-19: the Role of Sleep

NCT05606211 | Active Not Recruiting

• 1 other identifier: 2022P-000257
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (5)

• Pain reporting

  Daily pain severity reporting on rating scale from 0 to 10 (greater values indicate greater pain)

  14 days

• Pain sensitivity

  Pain thresholds to mechanical and temperature stimuli measured in kPa (pressure) and Celsius (heat). Lower values indicate lower pain thresholds.

  1 day

• Central pain modulation

  Capacity of the CNS to modulate pain

  1 day

• Wearable based sleep characteristics

  Estimation of sleep duration, fragmentation, regularity based on actigraphy

  2 weeks

• PSG based sleep characteristics

  Sleep stages and architecture based on PSG

  1 day

Study Arms (2)

Long COVID

Individuals who have been infected with the corona virus and developed Long COVID

Other: No intervention

No Long COVID

Individuals who have been infected with the corona virus and fully recovered.

Other: No intervention

Interventions

No intervention OTHER

Observational, no intervention

Long COVID; No Long COVID

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have been infected with the corona virus and developed or did not developed Long COVID.

You may qualify if:

• Females and males \>18 years
• Confirmed history of SARS-CoV-2 infection

You may not qualify if:

• History of chronic pain prior to SARS-CoV-2 infection
• Raynaud syndrome
• Pregnant/nursing

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, Serum

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 4, 2022
• Study Start: October 4, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)