NCT05148858

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

February 17, 2022

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

November 16, 2021

Last Update Submit

February 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    One month after the infection

Secondary Outcomes (2)

  • To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Epworth sleepiness scale (ESS).

    One month after infection

  • To assess quality of sleep in coronavirus 19 ( COVID-19) patients using Pittsburgh sleep quality index ( PSQI)

    One month after the infection.

Study Arms (2)

Cases

Patients affected by COVID-19 infection

Control

Normal subjects not affected by COVID-19 infection

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 32155789BACKGROUND
  • Wang 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.

    PMID: 32298802BACKGROUND
  • Tan 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.

    PMID: 32251513BACKGROUND
  • Hao 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.

    PMID: 32353518BACKGROUND
  • Nguyen 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.

    PMID: 32244415BACKGROUND
  • Ameri 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.

    PMID: 30173585BACKGROUND
  • Ibarra-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.

    PMID: 26417606BACKGROUND
  • Cardinali 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.

    PMID: 33015537BACKGROUND
  • Shrivastava 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.

    PMID: 32838114BACKGROUND
  • Sullivan 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.

    PMID: 33192172BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Manal Mahmoud

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 8, 2021

Study Start

April 1, 2022

Primary Completion

December 31, 2022

Study Completion

February 28, 2023

Last Updated

February 17, 2022

Record last verified: 2021-12