Sleep Quality and Quality of Life in Coronavirus 19 Disease ( COVID 19) Patients

February 16, 2022 updated by: Manal Mahmoud, Assiut University

Study the Patterns of Sleep Disturbance and Quality of Life During Corona Virus Disease 19 (COVID 19) Pandemic in Upper Egypt

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
Patients affected by COVID-19 infection
Control
Normal subjects not affected by COVID-19 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in coronavirus 19 disease ( COVID-19) patients
Time Frame: One month after the infection

Euro quality of life (Euro QoL) questionnaire in which higher scores mean a worse outcome.

Minimum value is 11111 Maximum value is 55555
One month after the infection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Epworth sleepiness scale (ESS).
Time Frame: One month after infection
ESS in which higher scores mean worse outcomes. ESS minimum value is zero, while maximum value is 24
One month after infection
To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Pittsburgh sleep quality index ( PSQI)
Time Frame: One month after the infection.
PSQI in which higher scores mean worse outcomes. PSQI minimum value is zero, while maximum value is 21
One month after the infection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Manal Mahmoud, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

December 4, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qol in Covid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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