COVID-19NCT05148858
Sleep Quality and Quality of Life in Coronavirus 19 Disease ( COVID 19) Patients
An observational study of COVID-19, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age below 18 years old. End stage organ failure. Patients with neurological, psychiatric diseases and cerebrovascular insufficiency.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients affected by COVID-19 infection | |
| Control | Normal subjects not affected by COVID-19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life in coronavirus 19 disease ( COVID-19) patients
Euro quality of life (Euro QoL) questionnaire in which higher scores mean a worse outcome.
Minimum value is 11111 Maximum value is 55555
Measured: One month after the infection
Secondary outcomes (2)
To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Epworth sleepiness scale (ESS).
ESS in which higher scores mean worse outcomes. ESS minimum value is zero, while maximum value is 24
Measured: One month after infection
To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Pittsburgh sleep quality index ( PSQI)
PSQI in which higher scores mean worse outcomes. PSQI minimum value is zero, while maximum value is 21
Measured: One month after the infection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Apr 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Mahmoud, Assiut University
- Investigators
- Manal Mahmoud, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148858
- Sponsor's protocol ID
- Qol in Covid
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.
PubMed 32155789Wang C, Pan R, Wan X, Tan Y, Xu L, McIntyre RS, Choo FN, Tran B, Ho R, Sharma VK, Ho C. A longitudinal study on the mental health of general population during the COVID-19 epidemic in China. Brain Behav Immun. 2020 Jul;87:40-48. doi: 10.1016/j.bbi.2020.04.028. Epub 2020 Apr 13.
PubMed 32298802Tan BYQ, Chew NWS, Lee GKH, Jing M, Goh Y, Yeo LLL, Zhang K, Chin HK, Ahmad A, Khan FA, Shanmugam GN, Chan BPL, Sunny S, Chandra B, Ong JJY, Paliwal PR, Wong LYH, Sagayanathan R, Chen JT, Ng AYY, Teoh HL, Ho CS, Ho RC, Sharma VK. Psychological Impact of the COVID-19 Pandemic on Health Care Workers in Singapore. Ann Intern Med. 2020 Aug 18;173(4):317-320. doi: 10.7326/M20-1083. Epub 2020 Apr 6. No abstract available.
PubMed 32251513Hao F, Tan W, Jiang L, Zhang L, Zhao X, Zou Y, Hu Y, Luo X, Jiang X, McIntyre RS, Tran B, Sun J, Zhang Z, Ho R, Ho C, Tam W. Do psychiatric patients experience more psychiatric symptoms during COVID-19 pandemic and lockdown? A case-control study with service and research implications for immunopsychiatry. Brain Behav Immun. 2020 Jul;87:100-106. doi: 10.1016/j.bbi.2020.04.069. Epub 2020 Apr 27.
PubMed 32353518Nguyen HC, Nguyen MH, Do BN, Tran CQ, Nguyen TTP, Pham KM, Pham LV, Tran KV, Duong TT, Tran TV, Duong TH, Nguyen TT, Nguyen QH, Hoang TM, Nguyen KT, Pham TTM, Yang SH, Chao JC, Duong TV. People with Suspected COVID-19 Symptoms Were More Likely Depressed and Had Lower Health-Related Quality of Life: The Potential Benefit of Health Literacy. J Clin Med. 2020 Mar 31;9(4):965. doi: 10.3390/jcm9040965.
PubMed 32244415Ameri H, Yousefi M, Yaseri M, Nahvijou A, Arab M, Akbari Sari A. Mapping the cancer-specific QLQ-C30 onto the generic EQ-5D-5L and SF-6D in colorectal cancer patients. Expert Rev Pharmacoecon Outcomes Res. 2019 Feb;19(1):89-96. doi: 10.1080/14737167.2018.1517046. Epub 2018 Sep 3.
PubMed 30173585Ibarra-Coronado EG, Pantaleon-Martinez AM, Velazquez-Moctezuma J, Prospero-Garcia O, Mendez-Diaz M, Perez-Tapia M, Pavon L, Morales-Montor J. The Bidirectional Relationship between Sleep and Immunity against Infections. J Immunol Res. 2015;2015:678164. doi: 10.1155/2015/678164. Epub 2015 Aug 31.
PubMed 26417606Cardinali DP, Brown GM, Reiter RJ, Pandi-Perumal SR. Elderly as a High-risk Group during COVID-19 Pandemic: Effect of Circadian Misalignment, Sleep Dysregulation and Melatonin Administration. Sleep Vigil. 2020;4(2):81-87. doi: 10.1007/s41782-020-00111-7. Epub 2020 Sep 26.
PubMed 33015537Shrivastava D. Unprecedented Events do not Always Call for Unprecedented Actions. Sleep Vigil. 2020;4(1):1-2. doi: 10.1007/s41782-020-00088-3. Epub 2020 May 25. No abstract available.
PubMed 32838114Sullivan CE. Snoring and obstructive sleep apnoea as risk factors in SARS-Cov-2: can nasal CPAP during sleep reduce pneumonia risk? Sleep Biol Rhythms. 2021;19(1):109-110. doi: 10.1007/s41105-020-00295-5. Epub 2020 Nov 7. No abstract available.
PubMed 33192172
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Patterns of Sleep Disturbance and Quality of Life During Corona Virus Disease 19 (COVID 19) Pandemic in Upper Egypt
- ClinicalTrials.gov ID
- NCT05148858
- Acronym / sponsor ID
- Qol in Covid
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients affected by COVID-19 infection |
| Control | – | –Normal subjects not affected by COVID-19 infection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Age below 18 years old. End stage organ failure. Patients with neurological, psychiatric diseases and cerebrovascular insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Epworth sleepiness scale (ESS).
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 32155789Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.
- Background: PubMed 32298802Wang C, Pan R, Wan X, Tan Y, Xu L, McIntyre RS, Choo FN, Tran B, Ho R, Sharma VK, Ho C. A longitudinal study on the mental health of general population during the COVID-19 epidemic in China. Brain Behav Immun. 2020 Jul;87:40-48. doi: 10.1016/j.bbi.2020.04.028. Epub 2020 Apr 13.
- Background: PubMed 32251513Tan BYQ, Chew NWS, Lee GKH, Jing M, Goh Y, Yeo LLL, Zhang K, Chin HK, Ahmad A, Khan FA, Shanmugam GN, Chan BPL, Sunny S, Chandra B, Ong JJY, Paliwal PR, Wong LYH, Sagayanathan R, Chen JT, Ng AYY, Teoh HL, Ho CS, Ho RC, Sharma VK. Psychological Impact of the COVID-19 Pandemic on Health Care Workers in Singapore. Ann Intern Med. 2020 Aug 18;173(4):317-320. doi: 10.7326/M20-1083. Epub 2020 Apr 6. No abstract available.
- Background: PubMed 32353518Hao F, Tan W, Jiang L, Zhang L, Zhao X, Zou Y, Hu Y, Luo X, Jiang X, McIntyre RS, Tran B, Sun J, Zhang Z, Ho R, Ho C, Tam W. Do psychiatric patients experience more psychiatric symptoms during COVID-19 pandemic and lockdown? A case-control study with service and research implications for immunopsychiatry. Brain Behav Immun. 2020 Jul;87:100-106. doi: 10.1016/j.bbi.2020.04.069. Epub 2020 Apr 27.
- Background: PubMed 32244415Nguyen HC, Nguyen MH, Do BN, Tran CQ, Nguyen TTP, Pham KM, Pham LV, Tran KV, Duong TT, Tran TV, Duong TH, Nguyen TT, Nguyen QH, Hoang TM, Nguyen KT, Pham TTM, Yang SH, Chao JC, Duong TV. People with Suspected COVID-19 Symptoms Were More Likely Depressed and Had Lower Health-Related Quality of Life: The Potential Benefit of Health Literacy. J Clin Med. 2020 Mar 31;9(4):965. doi: 10.3390/jcm9040965.
- Background: PubMed 30173585Ameri H, Yousefi M, Yaseri M, Nahvijou A, Arab M, Akbari Sari A. Mapping the cancer-specific QLQ-C30 onto the generic EQ-5D-5L and SF-6D in colorectal cancer patients. Expert Rev Pharmacoecon Outcomes Res. 2019 Feb;19(1):89-96. doi: 10.1080/14737167.2018.1517046. Epub 2018 Sep 3.
- Background: PubMed 26417606Ibarra-Coronado EG, Pantaleon-Martinez AM, Velazquez-Moctezuma J, Prospero-Garcia O, Mendez-Diaz M, Perez-Tapia M, Pavon L, Morales-Montor J. The Bidirectional Relationship between Sleep and Immunity against Infections. J Immunol Res. 2015;2015:678164. doi: 10.1155/2015/678164. Epub 2015 Aug 31.
- Background: PubMed 33015537Cardinali DP, Brown GM, Reiter RJ, Pandi-Perumal SR. Elderly as a High-risk Group during COVID-19 Pandemic: Effect of Circadian Misalignment, Sleep Dysregulation and Melatonin Administration. Sleep Vigil. 2020;4(2):81-87. doi: 10.1007/s41782-020-00111-7. Epub 2020 Sep 26.
- Background: PubMed 32838114Shrivastava D. Unprecedented Events do not Always Call for Unprecedented Actions. Sleep Vigil. 2020;4(1):1-2. doi: 10.1007/s41782-020-00088-3. Epub 2020 May 25. No abstract available.
- Background: PubMed 33192172Sullivan CE. Snoring and obstructive sleep apnoea as risk factors in SARS-Cov-2: can nasal CPAP during sleep reduce pneumonia risk? Sleep Biol Rhythms. 2021;19(1):109-110. doi: 10.1007/s41105-020-00295-5. Epub 2020 Nov 7. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal Mahmoud principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Mahmoud (01006502750, mahmoud82manal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in coronavirus 19 disease ( COVID-19) patients (time frame: One month after the infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148858, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.