Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT06291870

Conditions

Post Acute Sequelae of SARS CoV 2 Infection

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The CDC describes Post-acute sequelae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function.

Conditions

Post Acute Sequelae of SARS CoV 2 Infection

Obstructive Sleep Apnea

Study ID

NCT06291870

Start date

Jan 19, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All individuals 18 years or older, with prior history of COVID-19 infection diagnosis
  • Both genders including all racial and ethnic groups
  • Patients with OSA (apnea hypopnea index of 5/hour on polysomnography) with history of COVID-19 infection will be eligible with prior history of COVID-19 infection and without COVID-19 for Aim 2

Exclusion Criteria:

  • Inability to give consent
  • Active suicidal symptoms
  • Children of all ages
  • Pregnant women

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

COVID+

Patients with post-acute sequelae of SARS-COV-2 infection (PSAC) and obstructive sleep apnea (OSA)

Control

Patients with obstructive sleep apnea and no history of COVID-19

Primary outcome measure

  • Neurocognitive function Trails A and Trails B [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive function PASAT [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive function Stroop color-word interference [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive function DIGIT [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive function WASI [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive function WMS [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive function PVT [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive function HVLT-R [ Time Frame: Change from baseline at 3 months ]
  • Sleepiness ESS [ Time Frame: Change from baseline at 3 months ]
  • Sleep quality PSQI [ Time Frame: Change from baseline at 3 months ]
  • Quality of life SF-36v2 [ Time Frame: Change from baseline at 3 months ]
  • Quality of life FOSQ [ Time Frame: Change from baseline at 3 months ]
  • Quality of life SGRQ [ Time Frame: Change from baseline at 3 months ]
  • Fatigue Severity [ Time Frame: Change from baseline at 3 months ]
  • PROMISE Sleep Disturbance [ Time Frame: Change from baseline at 3 months ]
  • Horne and Osteberg Morningness/Eveningness Questionnaire [ Time Frame: Change from baseline at 3 months ]
  • Mini Mental State Examination (MMSE) [ Time Frame: Change from baseline at 3 months ]
  • Borg Scale [ Time Frame: Change from baseline at 3 months ]
  • Dyspnea: Six-minute walk test (6MWT) distance [ Time Frame: Change from baseline at 3 months ]

Central Contacts and Locations

Central contacts

Ruchi Rastogi, MS

(313) 576-4464ruchi.rastogi@va.gov

Locations

John D. Dingell VA Medical Center, Detroit, MI

Recruiting

Detroit, Michigan, United States, 48201-1916

Contacts

Ruchi Rastogi, MS

313-576-4464ruchi.rastogi@va.gov

Principal Investigator:

Susmita Chowdhuri, MD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • COVID-19
  • Quality of Life
  • Neurocognitive Function
  • Sleepiness
  • Sleep Quality
  • Six minute walk
  • Fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-23.