Clinical trial NCT05148858: Sleep Quality and Quality of Life in Coronavirus 19 Disease ( COVID 19) Patients
Official title: Study the Patterns of Sleep Disturbance and Quality of Life During Corona Virus Disease 19 (COVID 19) Pandemic in Upper Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mild, moderate and severe COVID 19 cases above 18 years old with no history of neurological, psychiatric disease or cerebrovascular insufficiency with no history of end stage organ failure.

Brief summary: To study the impact of COVID 19 infection on sleep habit as regards quality of sleep, emergence of insomnia.

To assess quality of life in patients after COVID 19 infection.

Detailed description: The year 2020 will be remembered for a cataclysmic event- the coronavirus disease 19 ( COVID 19) pandemic, caused by severe acute respiratory syndrome coronavirus 2.

COVID 19 is a serious disease that can significantly affect the daily lives of recovered patients and their families in terms of mental health problems such as post- traumatic stress, depression, anxiety, and insomnia, as well as the negative impact COVID 19 has on patients quality of life. Since the patients are not immune to future infection, it may lead to a more negative impact on patient's quality of life. Health related quality of life is an important measure that is used for assessing the impact of diseases, disorders, or disabilities on the physical, mental, and social domains of patients health. The assessment of health related quality of life (HRQol) helps healthcare providers identify the factors affecting quality of life (QoL) and recognize the aspects of COVID 19 management that needs to be enhanced for improving the QoL of patients. COVID 19 infection causes systemic inflammation leading to a surge on inflammatory mediators in the body that are known to influence sleep and vice versa.

Systemic infection related increase in the inflammatory mediators are known to increase the amount of non rapid eye movement (NREM) sleep and duration of sleep, perhaps in an attempt to save energy and counter the infection. However, different infections have varying effects on sleep. That could be one reason that COVID 19 infection has led to insomnia and worsening of sleep quality rather than increment in sleep. Not only the sleep quality has been affected during the COVID 19 pandemic, but pandemic could have led to emergence of sleep disorders as well.

It has been persuasively argued as to why elderly persons are more susceptible to contract severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection. Several factors have been discussed that worsens sleep among the elderly, including aging of the circadian network.

Considering high prevalence of these disorders, optimal management of these disorders is important during pandemic not only to reduce the risk of contracting SARS-COV-2 infection, but also to reduce adverse health consequences related to same.

This is an important area for research as the relationship appears bidirectional, improvement in sleep may be used to reduce impact of COVID 19 and vice versa.

Eligibility criteria: Inclusion Criteria:

* Mild, moderate and severe COVID 19 cases will be included in our study. Either diagnosed by polymerase chain reaction (PCR), CT changes characteristic of COVID 19 infection or by symptomatology and laboratory investigations.

Either managed as an outpatient or admitted to hospital. Either admitted to ward or to ICU. Age above 18 years old. With no history of end stage organ failure. With no history of neurological, psychiatric disease or cerebrovascular insufficiency.

Exclusion Criteria:

* Age below 18 years old. End stage organ failure. Patients with neurological, psychiatric diseases and cerebrovascular insufficiency.

Primary outcomes:
measure: Quality of life in coronavirus 19 disease ( COVID-19) patients
timeFrame: One month after the infection
Secondary outcomes:
measure: To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Epworth sleepiness scale (ESS).
timeFrame: One month after infection
measure: To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Pittsburgh sleep quality index ( PSQI)
timeFrame: One month after the infection.
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Manal Mahmoud
role: PRINCIPAL_INVESTIGATOR
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