CPAP Efficacy in Post-COVID-19 Patients With Sleep Apnea

NCT06052514 | Completed FDA Device

• 1 other identifier: STUDY23070113
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational study evaluating the relationship between severity of sleep apnea with severity of cognitive fog and if treatment of sleep apnea with CPAP improves cognitive fog in a cohort of post COVID patients with sleep apnea.

Conditions

COVID-19; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Montreal Cognitive Assessment at 4-6 Weeks

  Cognitive Fog as measured on Montreal Cognitive Assessment

  Baseline, 4-6 Weeks

Secondary Outcomes (9)

• Change from Baseline Digit span backwards and sequential in at 4-6 Weeks

  Baseline, 4-6 Weeks

• Change from Baseline in Trail making A and B test at 4-6 Weeks

  Baseline, 4-6 Weeks

• Change from Baseline in Digit symbol substitution at 4-6 Weeks

  Baseline, 4-6 Weeks

• Change from Baseline in Benson complex figure at 4-6 Weeks

  Baseline, 4-6 Weeks

• Change from Baseline in Stroop color word test at 4-6 Weeks

  Baseline, 4-6 Weeks

Study Arms (1)

Post COVID patient diagnosed with sleep apnea with AHI > 5

Patients with post COVID syndrome diagnosed with sleep apnea starting CPAP

Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressure DEVICE

Patients with moderate or severe OSA will be treated with CPAP

Post COVID patient diagnosed with sleep apnea with AHI > 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the post COVID clinic run by the Comprehensive lung Clinic at the Falk building, University of Pittsburgh.

You may qualify if:

• Patients more than 18 years of age.
• Diagnosed with COVID and continues to have persistent symptoms beyond 4 weeks.
• Diagnosed with sleep apnea based on a home sleep study

You may not qualify if:

• Patients with Narcolepsy or other acute Primary sleep problems.
• Cognitive impairment secondary to a neurodegenerative disorders and dementia.
• Acute exacerbation of psychiatric illness including severe depression, schizophrenia or bipolar disorder in the past 30 days.
• Serious medical or neurological illness or infection requiring hospitalization or unable to function in the past 30 days.
• Any medications that were started or change in dosage of the following medication in the past 30 days including: corticosteroids, stimulants, benzodiazepines/non benzodiazepine receptor agonists, antidepressants, antipsychotics or other medications which alter cognition.
• Patients who are on any active treatment for sleep apnea including CPAP, dental device or implant for two weeks before enrolling into the study.

Sponsors & Collaborators

• Venkatesh Krishnamurthy: lead
• Breathe Pennsylvania: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

COVID-19; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Venkatesh Krishnamurthy, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 25, 2023
• Study Start: January 4, 2024
• Primary Completion: December 21, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)