protocolSection identificationModule nctId: NCT06291870, orgStudyIdInfo id: F4396-P, secondaryIdInfos id: IRB-22-01-4294, type: OTHER, domain: John D. Dingell VA Medical Center, briefTitle: Predictors of Post-COVID Clinical and Cognitive Consequences, acronym: SCLC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-19, primaryCompletionDateStruct date: 2025-07-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, collaborators name: John D. Dingell VA Medical Center, descriptionModule briefSummary: 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., conditionsModule conditions: Post Acute Sequelae of SARS CoV 2 Infection, conditions: Obstructive Sleep Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Neurocognitive function Trails A and Trails B, primaryOutcomes measure: Neurocognitive function PASAT, primaryOutcomes measure: Neurocognitive function Stroop color-word interference, primaryOutcomes measure: Neurocognitive function DIGIT, primaryOutcomes measure: Neurocognitive function WASI, primaryOutcomes measure: Neurocognitive function WMS, primaryOutcomes measure: Neurocognitive function PVT, primaryOutcomes measure: Neurocognitive function HVLT-R, primaryOutcomes measure: Sleepiness ESS, primaryOutcomes measure: Sleep quality PSQI, primaryOutcomes measure: Quality of life SF-36v2, primaryOutcomes measure: Quality of life FOSQ, primaryOutcomes measure: Quality of life SGRQ, primaryOutcomes measure: Fatigue Severity, primaryOutcomes measure: PROMISE Sleep Disturbance, primaryOutcomes measure: Horne and Osteberg Morningness/Eveningness Questionnaire, primaryOutcomes measure: Mini Mental State Examination (MMSE), primaryOutcomes measure: Borg Scale, primaryOutcomes measure: Dyspnea: Six-minute walk test (6MWT) distance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: John D. Dingell VA Medical Center, Detroit, MI, status: RECRUITING, city: Detroit, state: Michigan, zip: 48201-1916, country: United States, contacts name: Ruchi Rastogi, MS, role: CONTACT, phone: 313-576-4464, email: ruchi.rastogi@va.gov, contacts name: Susmita Chowdhuri, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.33143, lon: -83.04575, hasResults: False